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Sr. Manager, Biostatistician

2 months ago

Princeton, United States G2 Startup Advisors Full time

Senior Manager, Biostatistician


About the Role:

Our client, a fast-growing global specialty pharmaceutical company, is seeking a Senior Manager, Biostatistician to oversee all statistical activities across development studies. This role involves managing vendor relationships, collaborating with internal teams, and establishing global standards.


Key Responsibilities:

  • Develop statistical sections of protocols and statistical analysis plans.
  • Interpret statistical analysis results for active development studies.
  • Collaborate with external statisticians and oversee vendor-performed statistical tasks.
  • Participate in vendor selection and review Requests for Proposal.
  • Develop integrated statistical analysis plans for regulatory submissions (NDA/BLA/MAA).
  • Ensure cross-study consistency in design and analysis.
  • Provide SAS programming and statistical analyses for publications and presentations.
  • Collaborate with internal teams to develop protocols, analysis plans, and clinical study reports.
  • Support process improvements and integration of new technologies.


Qualifications:

  • Education: PhD in Statistics or Biostatistics preferred; Master's with extensive experience considered.
  • Experience:
  • PhD with 3+ years in the pharmaceutical or healthcare industry, or
  • Master's with 8+ years of industry experience.
  • At least 2 years in designing studies and analyzing clinical trial data.
  • Technical Skills:
  • Proficient in SAS and R; Python experience is a plus.
  • Familiar with ICH guidelines (especially E9) and regulatory requirements.
  • Strong understanding of drug development and commercialization processes.