Associate Director, Biostatistics

Role Summary

Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area. The Associate Director, Biostatistics provides technical and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds. This includes 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. The incumbent may interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials. The incumbent works cross-functionally with internal departments and external resources on Biostatistics related issues and supports adherence to relevant 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, regulatory, and commercial teams. 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 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.
• 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

• Required: Advanced degree in Statistics or a related statistical discipline and a minimum of 7 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
• Required: Hands-on experience supporting clinical studies, working with clinical teams, and interacting with regulatory agencies.
• Required: Demonstrated ability to manage biostatistics deliverables at the study level.
• Required: Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry.
• Required: Hands-on statistical programming skills using SAS and/or R.
• Required: Ability to influence without direct authority.
• Required: Excellent verbal and written communication skills.
• Required: Ability to work independently and collaboratively in a fast-paced, matrixed environment consisting of internal and external team members.
• Required: Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Required: Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects.
• Preferred: Special knowledge or skills and/or licenses or certificates.
• Required: Excellent understanding of regulatory requirements and guidance documents.

Additional Requirements

• Travel: 5-15% of time.