Director, Biostatistics

Role Overview

• Provides technical leadership 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
• Implementing statistical analysis plans
• Authoring and implementing statistical analysis plans
• Interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders
• Interacting with regulatory agencies on matters related to the data for assigned clinical programs and/or trials
• Working cross-functionally with internal departments and external resources on Biostatistics related issues
• Ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate
• Ensuring the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material
• Developing solutions to statistical and data analysis issues for clinical and regulatory.
• Communicating solutions cross-functionally
• Participating in vendor evaluation, selection, and management
• Collaborating on protocol development including study design, endpoint selection, and power and sample size assessment
• Reviewing Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data in a way that supports a high-quality database for the 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.

Requirements

• A Master’s degree in Statistics or a related statistical discipline
• 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
• Proficient in Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
• 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.

Benefits

• Short
• and long-term incentives
• Medical, dental, vision, and retirement savings plans