Job Title: Sr. Manager/ Associate Director, Biostatistics
Location: Wayne, Pennsylvania
Type: Direct Hire - Full Time Permanent
Compensation: $175,000.00 - $200,000.00
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.
Responsibilities- 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.
Requirements - 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 supporting regulatory submissions and health authority interactions.
- Experience leading cross-functional teams and influencing development strategies.
- Expertise in statistical methods applicable to clinical development, including adaptive designs, longitudinal analyses, survival analyses, and integrated analyses.
- Experience overseeing CROs and external statistical vendors.
- Proficiency in SAS and/or R.
- Strong understanding of ICH, FDA, EMA, and other global regulatory guidance.
- Experience with real-world evidence, observational studies, HEOR, or post-marketing research is a plus.
- Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas is preferred.
System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
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