Director, Biostatistics

Role Summary

Director, Biostatistics responsible for leading the statistical strategy and execution for a clinical program. You will spearhead statistical efforts, contribute to the clinical development plan, regulatory submissions, and overall data strategy, with strategic involvement in program teams, authorship of statistical sections in study documents, and oversight of outsourced statistical functions.

Responsibilities

• Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams. Make strategic contributions to the clinical development plan.
• Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards.
• Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy.
• Develop and review statistical analysis plans for individual studies and integrated summaries of safety/efficacy (ISS/ISE). Create and edit statistical outputs shells.
• Provide statistical input during CRF design to ensure alignment with study objectives and analyze requirements. Oversee and quality control results from statistical programmers or CROs.
• Contribute to clinical study reports by authoring statistical sections and interpreting study results. Support the preparation of scientific publications and presentations.
• Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.
• May manage direct reports, as needed, providing guidance and professional development.

Qualifications

• Advanced degree in Statistics or related field with minimum 6 years of clinical trial experience in a biotechnology or pharma company.
• Extensive knowledge of statistical methods for clinical trials and deep familiarity with FDA, EMA, and ICH guidelines.
• Expertise in SAS required; R or Python is advantageous. Experience with trial design software such as EAST or nQuery.
• Strong communication skills necessary for effective collaboration with cross-functional teams. Ability to communicate statistics to non-statisticians effectively; influence and ensure adoption of robust statistical methods.
• Exceptional ability to manage multiple priorities in a fast-paced environment.
• A strong passion for innovation in Biostatistics and continuous improvement in processes.
• Strong analytical and problem-solving abilities.
• Positive attitude and a collaborative spirit.