Director, Biostatistics

Role Summary

The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and associated clinical trials for therapeutic areas and compounds. This includes identifying optimal study designs, defining data analysis strategies, implementing statistical analysis plans, interpreting findings, and communicating key messages to internal stakeholders and selected external stakeholders. The incumbent may interact with regulatory agencies on matters related to data for assigned clinical programs and/or trials. The role works cross-functionally with internal departments and external resources and ensures adherence to regulatory requirements and company SOPs.

Responsibilities

• Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations, and promotional material
• Develops solutions to statistical and data analysis issues for clinical and regulatory, and communicates solutions cross-functionally
• Participates in vendor evaluation, selection, and management
• Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment
• Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data to support a high-quality database for planned analyses
• Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions
• Authors and reviews statistical and outcome sections of study reports and submissions
• Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities
• Performs other tasks and assignments as needed and specified by management

Qualifications

• Master’s degree in Statistics or a related statistical discipline and a minimum of 8+ 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 understanding and working knowledge of advanced statistical theory and its application in the pharmaceutical/biotechnology industry
• Prior BLA, NDA and/or MAA experience is highly desirable
• Hands-on statistical programming skills using SAS and/or R
• Ability to influence without direct authority
• Proficient in Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Excellent understanding of regulatory requirements and guidance documents

Skills

• SAS and/or R programming
• Proficient in Microsoft Office
• Excellent verbal and written communication skills
• Ability to influence without direct authority
• Analytical thinking and problem-solving
• Ability to work in a fast-paced, matrixed, cross-functional environment

Education

• Master’s degree in Statistics or a related statistical discipline

Additional Requirements

• Travel: 5-15% of the time