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Associate Director - RWE Biostatistics - INCREDIBLE RELO PACKAGE

Company: i-Pharm Consulting
Location: Arlington
Posted on: November 11, 2019

Job Description:

This is your chance to join an industry leading Pharmaceutical organization, in a very exciting time! The Associate Director of Real World Evidence, Biostatistics will report directly to the Senior Director of Biometrics and act as the main point of contact for all RWE in relation to the oncology portfolio. Manage multiple, eager teams and benefit from strong company culture, great bonus structure, and eventual growth potential; becoming a future senior leader in a superior organization!
Responsibilities:

  • Lead/Manage several teams in Oncology portfolio and Outcomes Research to develop real world and payer evidence from post market products and trials
  • Analyze complex clinical data, including but not limited to biomarker data, and develop novel predictive models using statistical techniques and machine learning to support patient stratification and biomarker selection in clinical trials;
  • Lead the development of study protocols, statistical analysis plans (SAPs), programming specification and output documents
  • Guide the analytical team to clean and prepare small to large-sized real-world healthcare databases
    • Interacts and manages KOLs/CROs and represents the company in external scientific forums
    • Provides active coaching to biostatistical team members when developing solutions to problems. Manages team conflicts with external partners/customers
    • Contribute to study reports, including authoring the statistical sections and interpretation of the study results
    • Support regulatory submissions, including performing analyses for value base health technology assessment
    • Support the preparation of publications, including manuscripts, posters and oral presentations
      Job Qualifications
      • Ph.D. in Statistics or Biostatistics (with machine learning focus) required.
      • Ideally candidate has 5-7 years of work experience in the pharmaceutical industry with significant focus on statistical methodology.
      • Knowledge of FDA, EMA and ICH regulations and guidelines
      • Strong computational skills and expertise in frequentist and Bayesian methodologies are required

Keywords: i-Pharm Consulting, Washington DC , Associate Director - RWE Biostatistics - INCREDIBLE RELO PACKAGE, Executive , Arlington, DC

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