Associate Scientist, PK Analysis

Locations: US, Canada

Certara Strategic Consulting is now the largest and most comprehensive model-based drug development and strategic pharmacometrics organization, Certara Strategic Consulting brings together the resources of Certara’s leading consulting group, Pharsight Consulting Services (PCS) with scientific powerhouse, Quantitative Solutions. Deeply committed to our mission of bringing new, safer therapies to patients, we are scientists working with our clients to advance the discipline of modeling and simulation in drug development.

Key Responsibilities:

Associate may conduct any or multiple of the following activities as a billable consultant (~80% of “time in the office”), in the areas of PK and data management.

PK:

  • Associate PK tasks such as NCA, 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.

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).

Qualifications:

  • 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.

Skills & Abilities:

  • 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. WinNonlin, 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.

Working at Certara Strategic Consulting

Personal development is not only provided; it is expected. Certara Strategic Consulting is the largest pharmacometrics organization in the world, and we assure that various career pathways are offered to match the ambition and personal interests of their consultants.  Consulting allows for an optimal work-life balance. We prefer working together through office-based locations, but partially working from home is feasible

Applications:

Email resume to: hr@certara.com

OR

Send to:
Attn: Human Resources
Certara
5520 Dillard Dr., Suite 260
Cary, NC 27518

NO PHONE CALLS OR THIRD-PARTY AGENTS PLEASE.