Remote Associate Director Pharmacometrics & Modeler
Overview
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
Improved patient outcomes & increased patient access to medicines
Accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Our Pharmacometricians are responsible for supporting quantitative decision-making in drug development through the development and application of population PK, PK/PD, exposure-response and other models. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK, PK/PD, and/or exposure-response modelling and simulation to support drug development.
We are looking for Pharmacometricians that want to:
Deepen their strategic drug development expertise and their experience informing drug development decisions.
Hone their pharmacometric techniques with fit-for-purpose modelling approaches leveraging e.g. model-based meta-analysis, target-mediated drug disposition models, and E-R trial-simulations.
Broaden their drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
Develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests.
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Responsibilities
Support projects for Certaraโs clients by working in teams with other Associates, senior expert modelers, and drug development consultants.
Hands on pharmacometric modeling on client projects as a billable consultant.
Conduct quality control activities on model codes and reports.
May lead/coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).
May act as the primary point of contact for clients and collaborate with a senior consultant to grow business to match their interests.
Qualifications
PhD, MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, Engineering, Medicine, or related field.
1 to 5 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting is preferred, whether in academia or industry.
Expertise in PK/PD modelling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi-mechanistic components relating to mechanism of action and tailored to meet specific drug-development questions.
Proficiency in PK/PD and statistical software (e.g., NONMEM, R).
Proficient in modeling (e.g., popPK and PK/PD analyses, model-based meta- analysis, dose-response and exposure-response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings preferred.
Independent performance of analysis and modeling and development of reports with limited supervision.
Comfortable in a client environment able to communicate with and collaborate with peer scientists.
Developing ability to identify new business development opportunities through client interactions.
Proficient in spoken and written English. Certara is a global company, and additional languages are of benefit.
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Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
Certara is looking for talented and motivated Pharmacometricians/Modelers that are eager to:
Deepen their strategic drug development expertise and their experience informing drug development decisions.
Hone their pharmacometric techniques with fit-for-purpose modelling approaches leveraging e.g. model-based meta-analysis, target-mediated drug disposition models, and E-R trial-simulations.
Broaden their drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
Develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests.
In this role, most of your time will be spent performing pharmacometric analyses and providing recommendations to our clients. This position allows you to focus on your skills as a pharmacometrician and avoid distractions from other development activities. Our Pharmacometricians are responsible for supporting quantitative decision-making in drug development through the development and application of population PK, PK/PD, exposure- response and other models. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK, PK/PD, and/or exposure-response modelling and simulation to support drug development.
Responsibilities
Support projects for Certaraโs clients by working in teams with other Associates, senior expert modelers, and drug development consultants.
Hands on pharmacometric modeling on client projects as a billable consultant.
Conduct quality control activities on model codes and reports.
May lead/coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).
Lead and mentor other pharmacometricians.
May act as the primary point of contact for clients and collaborate with a senior consultant to grow business to match their interests.
Qualifications
PhD, MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, Engineering, Medicine, or related field.
6-10+ years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting is preferred, whether in academia or industry.
Expertise in PK/PD modelling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi-mechanistic components relating to mechanism of action and tailored to meet specific drug-development questions.
Proficiency in PK/PD and statistical software (e.g., NONMEM, R).
Proficient in modeling (e.g., popPK and PK/PD analyses, model-based meta- analysis, dose-response and exposure-response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings preferred.
Independent performance of analysis and modeling and development of reports with limited supervision.
Comfortable in a client environment able to communicate with and collaborate with peer scientists.
Developing ability to identify new business development opportunities through client interactions.
Proficient in spoken and written English. Certara is a global company, and additional languages are of benefit.
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
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.
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees! As one of Certaraโs divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Responsibilities
As PK-PD data programmer you manage and prepare data for state-of-the-art analysis, such as PopPK or drug exposure-response (PKPD), typically based on CDISC ADaM / SDTM datasets. You interact directly with the client on topics around data transfers, dataset specifications and data queries. You conduct exploratory analyses in support of these activities. Following completion of the project deliverables, you will create an electronic submission package for future submission to regulatory agencies. In addition, you will conduct quality control and quality assurance activities on datasets and reports, and may participate in company initiatives to improve efficiency of data management, analysis and reporting (IT, methodology, automation, quality).
As PK-PD data programmer you will work closely in teams with other associates, (experts) modelers and drug development consultants supporting a wide variety of client projects (therapeutic areas, data types
Qualifications
BSc, MSc or equivalent in Pharmaceutical- or Life Sciences, Statistics/Mathematics/Bio-Informatics, or related fields with 1- 5 yearsโ experience in data management and analysis, report writing, and regulatory drug submissions.
Advanced user of SAS software (SAS9-Base) with proven experience in life sciences and clinical trials. Familiar in working with CDISC data formats. Experience with the R software platform is a plus.
General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology.
Proficiency in conducting basic statistical analysis.
Accuracy and sense of urgency and quality, timely delivery.
Ability to work on multiple collaborative projects, team player mentality.
Excellent verbal and written communications skills in English.
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.
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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.
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.
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