The Director of Biostatistics will play a key role in providing statistical leadership across multiple Phase 2 and 3 clinical trials. As the statistical lead, you will develop and oversee statistical analysis plans, ensure the quality and accuracy of deliverables, and manage CRO partners to meet project timelines and standards. This role requires expertise in simulation work, multiple imputation analyses, and late-phase clinical development.
As the Director of Biostatistics, you will join a high-performing team of experienced drug developers dedicated to transforming outcomes for patients with autoimmune diseases. We are seeking someone with substantial filing knowledge and hands-on experience to play a critical role in the execution of the development of our lead compound. You will oversee the quality and accuracy of statistical analyses, and collaborate cross-functionally to develop integrated analyses for regulatory submissions. This role involves hands-on contributions to key statistical deliverables, such as analysis plans, clinical study reports, and data packages for regulatory submissions, while managing CROs and mentoring junior team members.
Essential Responsibilities:
• Apply advanced statistical methods to clinical trial data summaries and interpretations including integrated safety and efficacy analyses to support regulatory submissions.
• Provide statistical input for drug development plans, clinical study design, and operationalization.
• Perform as study statistician including the development or review of statistical analysis plans, clinical study reports, and presentations.
• Manage and oversee CROs.
• Ensure the quality and accuracy of study data and statistical outputs.
• Perform quality control checks on key efficacy and safety endpoints to validate data.
• Mentor junior staff and contractors, while primarily serving as an individual contributor.
Education:
• Ph.D. in Biostatistics with at least 8 years of experience, or Master’s with a minimum of 10 years of directly relevant experience in the biopharma industry.
Experience:
• Strong expertise in statistical experimental design, clinical trial analysis, and regulatory requirements.
• Proven track record of planning, creating, and delivering Integrated Summaries of Safety and Effectiveness (ISS and ISE) and related reports for regulatory submissions.
• Proficiency with R and SAS software.
• Immunology experience preferred.
• Proven ability to manage deliverables with competing priorities.
Skills:
• Excellent analytical thinking, attention to detail, and communication (written and oral).
• Demonstrated ability to work in a regulated environment and adhere to SOPs.
• Strong interpersonal skills and ability to influence cross-functional teams.
• Experience coaching and managing biostatistics staff is a plus.
