\nWhy join Freenome?\n\nFreenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. \n\nCancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and itโs just the beginning. \n\nFounded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection. \n\nAt Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.\n\nBecome a Freenomer\n\nDo you have what it takes to be a Freenomer? A โFreenomerโ is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patientsโ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve whatโs possible, one breakthrough at a time.\n\nAbout this opportunity:\n\n\nAt Freenome, we are seeking a Director of Cloud Infrastructure to lead our Infrastructure team that is providing the services for early cancer detection blood tests as well as other company wide initiatives. The ideal candidate is a servant-leader that is comfortable managing a growing team, focused on meeting the needs of internal customers, navigating ambiguity and adapting to rapid change. You are passionate about building a healthy, collaborative work environment and are a steward of our cultural values. You have demonstrated the ability to lead teams in building infrastructure in a regulatory industry and you have the potential to have a significant impact on the continued growth of a high profile technology organization that is changing the landscape on early cancer detection.\n\n\nThis role reports to our Vice President, Software Engineering.\n\n\nWhat youโll do:\n\nExecution Excellence\n\n\n* Provide direct, strategic and tactical leadership to your department \n\n* Provide leadership in developing new strategies, methodologies, and solutions to improve execution towards department- and company-level objectives\n\n* Partner with our QA Department to ensure the highest level of regulatory compliance with recognized quality best practice\n\n* Translate business segment strategy into cross-functional plans and guide plan execution\n\n* Accountable for the performance and results of your department (Monitoring performance and initiating action to strengthen results)\n\n* Proactively communicate cross-functionally with key stakeholders to adapt as needed through reprioritization and alignment \n\n* Ensure budgets, resourcing and timelines meet company requirements\n\n* Empowers department to take calculated risks and make mistakes as a team but collectively learn from these experiences, ensuring institutional knowledge is retained and applied in the future\n\n* Comfortable navigating ambiguity, using trial and error to thoughtfully iterate towards the best solution balancing time and resource constraints\n\n* Anticipate factors that could cause issues that have departmental or cross-functional impact and formulates preventive strategies \n\n\n\n\nCommunication and Collaboration\n\n\n* Proactively requests feedback from others and are open to continuous feedback\n\n* Consistently delivers actionable and timely feedback to people at all levels in a way that strengthens relationships and enables functional initiatives to advance more quickly\n\n* Provide consistent communications to key functional and cross-functional stakeholders on progress and updates \n\n* Guides department in effective communication and collaboration, avoiding triangulation or churn and fostering direct communication\n\n* Adapts communications to audience requirements to optimize understanding and results, adapting to diverse communication styles\n\n* Build and maintain strong, healthy relationships with cross-functional peers \n\n* Provide representation for your department to executive leadership through reporting, presentations and Quarterly Business Review type meetings\n\n\n\n\nCulture\n\n\n* Lead by example, integrate and reinforce our Values and Principles as much as possible\n\n* Coaches and provides guidance to direct reports to foster our Values and Principles across departments\n\n* Recognizes Values and Principles gaps in your department on an ongoing basis and implement solutions and creates opportunities to grow in those areas\n\n\n\n\n\nPeople Leadership\n\n\n* Actively identifies internal transfer and growth opportunities, empowering team members to pursue them\n\n* Perform quarterly talent reviews \n\n* Addresses performance issues with direct, constructive and actionable feedback\n\n* Provides inspiration and leads department towards the company mission, vision, and culture\n\n* Gives direction and organizational clarity in roles and responsibilities to execute on department and company OKRs more effectively\n\n* Effectively cascades organizational strategy and contributes to the development of organizational procedures\n\n* Actively involved in recruitment, attracting and retaining top talent to build high performing teams\n\n\n\n\n\nMust haves:\n\n\nBS, MS or Ph.D. in Computer Science, Engineering or a related field; or equivalent training, fellowship, or work experience\n\n5+ years of experience in engineering leadership and management\n\n3+ years of infrastructure experience with a track record of building and deploying infrastructure as part of a high-functioning team\n\nMulti-public cloud experience (AWS, Azure, GCP)\n\nDeep knowledge and proven working experience in managing Kubernetes and cloud infrastructure services, networking, security\n\nProven experience in leveraging automation tools and infrastructure-as-code techniques as a key strategy for managing infrastructure\n\nProven experience implementing Site Reliability Engineering (SRE) practices\n\nProven expertise in building high performance teams\n\nA demonstrated ability to structure, grow, and optimize a team for execution, including attracting top talent and filling in gaps in the existing team quickly to accommodate growth\n\nExperience with project management and prioritization, risk management, problem-solving, and resource planning\n\nExcellent verbal and written communication skills up, down, and peer to peer\n\nStrong leadership and collaboration skills\n\n\n\n\n\nNice to haves:\n\n\n* Experience in biotechnology, bioinformatics, regulated software, or similar field \n\n* Experience in a startup environment\n\n* Experience leading teams in a highly regulated environment\n\n* Experience leading teams developing infrastructure as part of a Medical Device\n\n* Exposure to big data, especially biological and clinical data\n\n\n\n\n\nBenefits and additional information:\n\nThe US target range of our base salary for new hires is $197,20 - $304,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Companyโs sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information. \n\nFreenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.\n\nApplicants have rights under Federal Employment Laws. \n\n\n* Family & Medical Leave Act (FMLA)\n\n* Equal Employment Opportunity (EEO)\n\n* Employee Polygraph Protection Act (EPPA)\n\n\n\n\n#LI- Remote \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Cloud and Cloud jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBrisbane, California, United States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nWe are looking for a Senior Director Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.\n\n\n\n\n\nYour priorities will include:\n* As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.\n* Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.\n* Provide expert statistical input and consultancy to Phase I โ IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.\n* Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.\n* Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.\n* Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.\n* Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.\n* Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).\n\n\n\nWe'd love to hear from you if you have:\n* Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.\n* Successful project and people management and expertise in the development of Alzheimer's Disease and Neuroscience programs (change to Neuroscience or Rare Disease programs).\n* Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.\n* Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.\n* Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.\n* Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.\n* Demonstrated strong leadership, project management, collaboration, communication, and organization skills.\n* Advanced programming skills in SAS, R and other relevant statistical software solutions.\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.\n* Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.\n\n\n\n\n\n$280,000 - $303,000 a yearBase salary ranges will be determined by the candidateโs level, qualifications, skill set, and experience.\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together. \n\n\nAmong the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each otherโs assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws. \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. \n\n\nReview our Privacy Policy \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$57,500 — $90,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nUnited States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n\n\n\n\nAlpine Immune Sciences (AIS) is seeking an Associate Director-Clinical Documents (eTMF) to serve as an operational lead for management and oversight of the trial master file (TMF) system at AIS. This person works in partnership with the study teams in order to ensure trial documents are complete, high quality, and appropriately filed within the TMF system. \n \nDuties and responsibilities:\nยท Establish strategy for development and management of paper and electronic Trial Management File (eTMF) system through project management and hands-on participation in the configuration and maintenance of the eTMF for each study.\nยท Support authoring of TMF Management Plans and provide TMF Indices; work with study teams to check and verify these plans.\nยท Provide guidance on best practices for clinical trial records handling, retrieval, and archival procedures.\nยท Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to TMFs.\nยท Participate in and oversee the quality control of documents (paper and electronic) submitted to the TMF.\nยท Support the coordination of the transfer of study specific TMF from CROs into the AIS TMF, if applicable.\nยท Educate and support study teams and designated study team content owners in understanding their TMF-related responsibilities, requirements, and expectations; act as an ad-hoc member of the study team, as necessary.\nยท Act as a point person for study team TMF questions and manage close-out of TMF related issues.\nยท Provide TMF metrics: timeliness, completeness, and quality of TMF documentation and content, and the risk level of outstanding items as requested.\nยท Identify any corrective actions which must be assigned and addressed.\nยท Provide document records to users (e.g., internal staff and/or auditors) for review including archived records. \nยท Oversee the provision of the required documents at the time of regulatory authority inspection or internal audits.\nยท Respond to TMF and non-TMF internal and external information inquiries related to clinical trial records.\nยท Identify opportunities for continuous improvement.\nยท Manage in-line QC functions for TMF documentation including site regulatory documentation to evaluate and report whether deliverables are completed per contracted services and are in compliance with all appliable local, federal, and international regulations, guidelines, AIS policies, SOPs, and work instructions.\nยท Manage, mentor and train individuals reporting into this position, if applicable.\nยท Actively support inspections and audits.\nยท Resource planning to support TMF activities.\nยท Perform other duties as assigned.\n \nQualifications:\nยท Bachelorโs degree preferred, or equivalent knowledge/experience gained through a minimum of 8 yearsโ experience in the clinical trial setting required.\nยท Must have strong knowledge of clinical drug development processes. \nยท Understanding of the planning, launching, maintenance, and closure of Phase I-IV clinical trials, including global clinical trials. \nยท Experience in successfully working with TMF systems.\nยท Demonstrated successful setup and management of TMF systems. \nยท Thorough knowledge of CFR, ICH/GCP, and GDPR/data privacy requirements. \nยท Self-starter comfortable working in a hybrid work environment with department and cross-functional colleagues based in different geographies.\nยท Resourceful with keen critical thinking skills; ability to successfully research a variety of topics, including obtaining input from colleagues to drive solutions. \nยท Ability to anticipate issues and outcomes and respond strategically, proposing โoutside the boxโ, goal-oriented solutions to challenges in alignment with project and company objectives and values.\nยท Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.\nยท Proven leadership and interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.\nยท Ability to review and analyze performance metrics through various systems.\nยท Proficiency with MS Word, Excel, PowerPoint, SharePoint; Smartsheet experience a plus.\nยท Experience giving presentations in both department and multidisciplinary settings. \n \nEssential Traits: \nยท Leads by example and learns from mistakes.\nยท Effectively pivots to meet changing demands in priorities when business needs dictate.\nยท Completes tasks on time to meet milestones, comfortable proactively communicating to stakeholders if timelines are at risk.\nยท Clearly communicates milestones, risks, mitigations, and essential feedback.\nยท Values the input of colleagues. \nยท Works efficiently without compromising quality.\nยท Continually seeks self and team improvement.\nยท Innovates and eliminates redundant, inefficient, and manual processes where feasible.\n\n\n#LI-remote\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position has a compensation range of $165,000 - $200,000. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโs culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโguided by our core values, weโll meet these challenges. Join us!\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Education jobs that are similar:\n\n
$60,000 — $100,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.
\nOur mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history \n\n\nWe are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.\n\n\n\n\n\nYour priorities will include:\n* As the lead Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.\n* Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.\n* Provide expert statistical input and consultancy to Phase I โ IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.\n* Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.\n* Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.\n* Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.\n* Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.\n* Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).\n\n\n\nWe'd love to hear from you if you have:\n* Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.\n* Successful project and people management and expertise in the development of CNS diseases.\n* Thorough knowledge of life cycle management; consistent track record of innovatively applying statistical principles, theories, and concepts to clinical drug development leading to regulatory approvals.\n* Deep hands-on operational experiences in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings.\n* Up to date knowledge of industry and academic developments in the Neuroscience, and apply them to clinical study design and analysis.\n* Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.\n* Demonstrated strong leadership, project management, collaboration, communication, and organization skills.\n* Advanced programming skills in SAS, R and other relevant statistical software solutions.\n* Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.\n* Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.\n\n\n\n\n$250,000 - $290,000 a yearBase salary ranges will be determined by the candidateโs level, qualifications, skill set, and experience.\n\n#LI-BL1\n#LI-Remote\n\n\nAt Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together. \n\n\nAlector was named on Fortuneโs "Best Workplaces in Biopharma" top list for small and medium-sized companies for the third consecutive year! And we moved up from #16 to #11 in 2022. \nAmong the things you'll discover at Alectorfrom your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! \n \nWe believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each otherโs assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws. \n\n\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$45,000 — $85,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nUnited States
๐ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!
When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.