Associate Director, Biostatistics; Late Stage

Job Summary

Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This role contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. The position guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses, while interacting with study teams, as well as statisticians and programmers  role works under some supervision to solve complex study problems.

• Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis file development, statistical analysis accuracy validation, results interpretation, and CSR input and review. Acts as main statistical contact for the assigned studies and projects.
• Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.
• Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.
• Reviews CRO/vendor proposals and budgets, establishes procedures through regular interaction, sets expectations on deliverables and timelines to guide CRO biostatistician and statistical programmers, and ensures deliverables are accurate and delivered according to the timelines.
• Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document, and may participate in meetings or teleconferences with Health Authorities.
• Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development, leading to cost savings and shortened timelines for the company.

Education Qualifications

• Master's Degree in Statistics or Biostatistics required.
• PhD in Statistics or Biostatistics preferred.

Experience Qualifications

• 8+ Years of relevant experience in the pharmaceutical industry with a master’s degree required.
• 5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred.

Travel Requirements

• Ability to travel up to 10% of the time.

Daiichi Sankyo, Inc. 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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