Provides technical and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds
Identifying optimal study designs
Defining data analysis strategies
Authoring and implementing statistical analysis plans
Interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders
May interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials
Works cross-functionally with internal departments and external resources on Biostatistics related issues
Supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

Advanced degree in Statistics or a related statistical discipline
Minimum of 7 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment
Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies
Demonstrated ability to manage biostatistics deliverables at the study level
Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry
Hands-on statistical programming skills using SAS and/or R

Associate Director, Biostatistics

Key skills