Director, Biostatistics

Role Summary

Director, Biostatistics. Oversee the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance. Lead a Biometrics team, drive strategic initiatives, and collaborate cross-functionally to meet company goals.

Responsibilities

• Serve as the point of escalation to ensure the timeliness and accuracy of Biometric deliverables.
• Drive development and adherence to Biometric vision, strategy, and operational excellence for global development programs.
• Anticipate new challenges, risks, and needs for the department, and proactively mitigate to ensure business continuity.
• Oversee performance of external vendors responsible for clinical data deliverables to ensure quality completion of all clinical data related deliverables.
• Serve as the strategic partner working closely with other relevant functions to ensure statistical input into strategy, design, and execution of clinical development plans and trial designs.
• Ensure expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally and externally.
• Lead development of new / streamlining procedures and process improvement to meet the needs of an evolving Biometrics Department.
• Drive development and improvement of department-level standard operating procedures (SOPs).
• Collaborate with partner functions to provide statistical programming, systems analysis, and database management support for important Clinical Development deliverables.
• Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements.
• Ensure all data management activities and processes follow GCP, regulatory requirements, and SOPs/WIs; ensure CDISC standards compliance.
• Responsibly delegate tasks.

Qualifications

• Master's degree or higher in Statistics/Biostatistics.
• 8+ years of experience in pharma/biotech with knowledge of Data Management and Biostatistics processes.
• 3+ years of experience managing a team, including project leadership and staff development.
• Strong expertise in clinical data management for Phases I-IV trials and complex study designs.
• Strong working knowledge of Biostatistics processes.
• Experience managing outsourced data management models.
• Extensive experience with Medidata RAVE and other EDC platforms.
• Thorough knowledge of GCP, ICH, and FDA/regulatory requirements as applicable.
• Effective cross-functional leadership and people management skills.
• Strong verbal and written communication and relationship-building skills.
• Strong organizational skills and ability to prioritize in a fast-paced environment.
• Familiarity with CDASH and SDTM standards.
• Strong analytical thinking, problem-solving abilities, and attention to detail.