Director Biostatistics

- Lead the full scope of Biostatistics activities for assigned clinical programs or indications

- Define and execute statistical strategies for clinical trials and regulatory submissions

- Design clinical studies, including endpoints, estimands, and sample size calculations

- Serve as statistical lead on Study Executive Teams and Clinical Development Teams

- Provide quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical success

- Ensure quality and timely delivery of statistical outputs, including interim, final, and integrated analyses

- Contribute to regulatory submissions (e.g., NDA) and represent Biostatistics in interactions with FDA

- Collaborate cross-functionally with Clinical, Medical, and Regulatory

- Oversee CROs and/or internal teams; ensure quality, timeliness, and compliance of deliverables

- Collaborate with internal leaders of Statistical Programming and Data Management

- Supervise statistical programmers for QC and validation activities

- Interpret analysis results and ensure accuracy in study reports, publications, and regulatory documents

- Contribute to abstracts, posters, and presentations for internal and external stakeholders

- Drive continuous improvement initiatives within Biostatistics and cross-functional processes

- PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience OR MS with ~11+ years of experience in drug development

- Demonstrated experience providing statistical leadership at study or program level

- Strong experience designing clinical trials and collaborating with cross-functional teams

- Experience interacting with regulatory authorities preferred

- Experience supervising programming deliverables or QC activities

- Strong knowledge of CDISC standards, data structures, and statistical methodologies

- Working knowledge of SAS and/or R (oversight level, not heavy programming)

- Therapeutic area experience flexible; preference for chronic diseases or larger patient populations

- Strong understanding of clinical development processes and regulatory expectations

- Excellent communication skills; able to translate statistical concepts to non-statistical audiences

- Analytical rigor with a pragmatic, execution-oriented mindset