Certara is hiring Pharmacometricians to support our Integrated Drug Development division! This position can be based in any of our US offices, or full time remote.
About our Integrated Drug Development Division:
IDD, a division of Certara, integrates advanced simulation approaches into the most crucial drug development deliverables. Our consulting organization informs internal decision-making by clients in the pharmaceutical and biotech sectors and strengthens their submissions to regulatory agencies in the United States and globally. Leveraging our experience working on thousands of key drug development projects on behalf of hundreds of biopharma companies, we bring a record of success and a broad range of experience to every assignment.
- Associate may conduct any or multiple of the following activities in the areas of PK and data management:
- Associate PK tasks such as NCA, entry level Modeling and Simulation, creation of TFL, authoring of CSR PK sections, ADA summaries.
- Performs noncompartmental analyses (NCA), creation of tables, figures and listings (TFL), authoring of pharmacokinetic (PK) sections in Clinical Study Report, Regulatory Modules, PK analysis plans and ADA summaries.and/or Performs entry level Modeling and Simulation skills (popPK).
- Data Management
- Conducts data-management in support of CSRs and modeling.
- Construct datasets and/or databases in support of PK modeling or model-based meta analyses (Trial Specialist).
- Conducts quality control and quality assurance activities on datasets and reports.
- May participate in company initiatives to improve efficiency of dataset construction, analysis and reports (e.g. IT, methodology, efficiency, automation, quality).
Skills & Abilities
- BS, MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
- Minimum 1- 5 years’ experience and expertise in PK analysis, data management, reporting writing, and regulatory requirements.
- General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred.
- Proficiency in performing PK and statistical analysis using software (e.g., WinNonlin), and optimally statistical analysis using software (SAS/R).
- Proficiency in performing PK using software (e.g. NONMEM, Phoenix WinNonlin, AutoPilot) or is an expert in dataset construction (e.g. R, S-plus, SAS).
- Entry level developing modeling skills preferred
- R skills a plus
- Ability to support and coordinate multiple projects as requested.
- Excellent verbal and written communications skills in English.
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
The wellbeing of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
- Financial – competitive pay, incentives, retirement plans, income security programs
- Health and Wellness – comprehensive benefit package, wellness programs, healthy lifestyle office environments
- Work/Life –unlimited paid time off and an employee assistance program
- Growth & Development – performance driven environment
- Community Impact – volunteering opportunities, matching gifts, charitable contributions
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.