Senior Biostatistician

1 month ago

Atlanta, Georgia, United States Daiichi Sankyo Full time
Biostatistics Manager Job Description

About Daiichi Sankyo

Daiichi Sankyo is a global pharmaceutical company dedicated to improving the lives of people around the world. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to providing novel therapies in oncology and other research areas.

Job Summary

We are seeking a highly skilled Biostatistics Manager to lead statistical support for medium complexity studies. The successful candidate will contribute to the development of optimal study design, independently develop and execute statistical analysis plans, and help interpret results with some supervision.

Key Responsibilities

  • Protocol Development, Case Report Form (CRF) Review, Statistical Analysis Plan (SAP) Development, Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR) Input and Review
  • Drug Development Strategy: Provide input to multiple aspects of the development plan to ensure study designs at each phase are scientifically sound and deliver the pre-specified product profile
  • CRO/Vendor Oversight: Review CRO/vendor proposals and budgets, establish procedures, and ensure deliverables are accurate and delivered according to timelines
  • Global Health Authority Interaction/Negotiation: Contribute to documents submitted to Health Authorities globally by providing input for interactions or writing interaction documents
  • Global Strategy to Improve Drug Development: Participate in and occasionally lead moderately complex biostatistical initiatives to improve harmonization and efficiency of drug development

Qualifications

The ideal candidate will have a PhD in statistics or biostatistics, with 3+ years of relevant experience in the pharmaceutical industry. A Master's degree in statistics/biostatistics with 6+ years of experience is also acceptable.

Daiichi Sankyo is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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