Director, Biostatistics

136711
  • 220000 USD - 280000 USD
  • ., United States
  • Permanent

We have partnered with a rapidly growing biopharma seeking a Director, Biostatistics to join the team. The Director of Biostatistics will work with cross-functional teams on the design, analysis, and reporting of clinical studies; provide statistical expertise and defense of regulatory submissions; and support the company’s external publications and corporate objectives.

RESPONSIBILITIES:

  • Write statistical sections of protocols. Author SAPs, and efficacy results sections of CSRs.
  • Design and implement clinical studies by overseeing the development of statistical sections of study protocols and statistical analysis plans.
  • Partner with vendor CROs in the timely and quality execution of deliverables including analysis plans and outputs for individual studies and pooled analyses.
  • Provide statistical support and analyses for regulatory meetings, submissions, and regulatory defense.
  • Provide statistical consultation to cross-functional groups.

QUALIFICATIONS:

  • PhD in Statistics with 8 years of experience working in clinical development in a pharmaceutical, biotechnology, or CRO industry environment or an MS in Statistics with 10 years of experience.
  • Excellent verbal and written communication skills; ability to work in a team environment with medical personnel, clinical monitors, programmers, data managers and medical writers. Attention to detail is required.
  • Knowledge of FDA/ICH guidelines. Experience with preparation of NDAs, briefing documents, and responses to questions from regulatory agencies is required.

If you are interested in learning more about this opportunity, please reach out to Marina Menchero at marina@peoplewithchemistry.com.

Marina Menchero Division manager

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