Associate Director/Director, Biostatistics

ITF TherapeuticsConcord, MA
35d$210,000 - $250,000

About The Position

We are seeking an experienced Associate Director/ Director of Biostatistics to support strategic and operational biostatistical activities across post-marketing programs. This hands-on role will provide scientific and statistical leadership to support Global Medical Affairs evidence generation for observational studies, and real-world evidence generation, with a strong focus on Medical Affairs, Market Access, and pharmacoepidemiology. This role ensures robust data interpretation, compliance with regulatory standards, and strategic insights for medical decision-making.

Requirements

  • Ph.D. or M.S. in Biostatistics, Statistics, or related field.
  • Minimum 7 years in biostatistics within the pharmaceutical or biotech industry.
  • Proven leadership in post-marketing research.
  • Strong background in Medical Affairs.
  • Proficiency in SAS, R, and advanced statistical methodologies.
  • Familiarity with real-world data sources and epidemiological study designs.
  • Excellent communication and leadership abilities.
  • Ability to influence and collaborate across global, matrixed teams.

Nice To Haves

  • Experience in Market Access analytics preferred.
  • Experience in pharmacoepidemiology preferred.

Responsibilities

  • Design and execute statistical analyses for observational studies, registries, and post-marketing research.
  • Develop statistical analysis plans (SAPs) for real-world data and medical affairs projects.
  • Apply advanced methods (e.g., survival analysis, propensity score matching, mixed models) to assess treatment patterns, outcomes, and disease burden.
  • Lead epidemiological assessments of disease prevalence, incidence, and natural history.
  • Support development of burden-of-illness and health economics models.
  • Collaborate on protocol design for non-interventional studies and patient registries.
  • Provide statistical input for scientific platforms, publications, and congress presentations.
  • Interpret data for medical information responses, advisory boards, and educational materials.
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