Sr. Manager​/Associate Director, Biostatistics

Job Title: Sr. Manager/ Associate Director, Biostatistics

Location: Wayne, Pennsylvania

Type: Direct Hire – Full Time Permanent

Compensation: $ - $

Work Model: Hybrid – 2 days onsite

Hours: 40.0

Join a growing clinical-stage biotechnology company at a pivotal point in development, where you'll serve as a key statistical partner on late-stage clinical programs and have the opportunity to directly influence study strategy, regulatory submissions, and the path to potential commercialization.

• Lead the biostatistics strategy for one or more clinical development programs and studies.
• Serve as the statistical representative on cross-functional study teams, Clinical Development Teams, and governance committees.
• Collaborate with Clinical Development and Medical teams to design clinical studies aligned with program objectives, regulatory expectations, and business needs.
• Provide strategic input into clinical development plans, including study design, endpoint selection, sample size determination, interim analyses, and decision criteria.
• Identify potential statistical, operational, or scientific challenges and proactively develop solutions.
• Evaluate and implement innovative statistical methodologies to enhance development strategies and study efficiency.
• Support quantitative decision-making, including benefit-risk assessments, probability of technical success analyses, and Go/No-Go evaluations.
• Author and/or review statistical sections of protocols, statistical analysis plans (SAPs), data review plans, and study reports.
• Develop and oversee analysis strategies, including tables, listings, and figures (TLFs), ensuring methodological rigor and regulatory compliance.
• Ensure timely delivery and quality of statistical analyses for interim reviews, final analyses, integrated summaries, and regulatory submissions.
• Interpret study results and effectively communicate findings to technical and non-technical audiences.
• Prepare and review abstracts, posters, manuscripts, presentations, and scientific publications.
• Contribute to regulatory strategies and support global submissions.
• Represent Biostatistics during interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies.
• Support responses to regulatory questions related to study design, analysis methodologies, and interpretation of results.
• Ensure statistical deliverables meet applicable ICH, FDA, EMA, and other global regulatory requirements.
• Provide statistical leadership for post-marketing studies, observational research, registry studies, real-world evidence initiatives, and outcomes research activities.
• Collaborate with cross-functional partners to identify evidence gaps and develop analytical approaches.
• Contribute statistical expertise to publications, scientific communications, and evidence dissemination activities.
• Oversee CROs, functional service providers, and external statistical vendors to ensure high-quality deliverables and adherence to timelines.
• Collaborate with Statistical Programming and Data Management to ensure data quality and efficient analysis execution.
• Support departmental initiatives focused on process improvement, innovation, quality standards, and inspection readiness.
• Contribute to the development and maintenance of statistical standards, procedures, and best practices.

• Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 6 years of relevant pharmaceutical industry experience; or M.S. with a minimum of 8 years of experience.
• Demonstrated experience providing statistical leadership for clinical development programs and clinical trials.
• Strong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements.
• Experience…