Associate Director, Biostatistics

About the role

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

Responsibilities

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

Requirements

• Master’s Degree in statistics or biostatistics required; PhD in statistics or biostatistics preferred.
• 8+ years of relevant experience in the pharmaceutical industry with a master’s degree required; 5+ years with a PhD preferred.
• Ability to travel up to 10% of the time.

Pay

Salary Range: USD $175,440.00 – USD $263,160.00