Description:
The Director, Data Management & Biostatistics provides strategic and operational leadership for all data management, biostatistics, and statistical programming activities supporting the company's pharmaceutical development portfolio. This role ensures the highest standards of data integrity, statistical rigor, and regulatory compliance across all phases of clinical development (Phase I–IV), enabling informed decision-making and successful global regulatory submissions. The Director partners closely with Clinical Development, Medical Affairs, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality, and external partners to deliver high-quality, inspection-ready data and analyses in accordance with FDA, EMA, ICH, and GxP requirements.
Essential Functions:
- Define and execute the biometrics strategy for clinical development programs in alignment with portfolio and regulatory objectives.
- Provide scientific leadership on study design, endpoint selection, statistical approaches, and data standards.
- Serve as the primary biometrics advisor to clinical development leadership and governance committees.
- Oversee end-to-end clinical data management activities, including EDC setup, CRF design, data cleaning, reconciliation, and database lock.
- Ensure compliance with CDISC standards (SDTM, ADaM) and internal SOPs; Partner with Clinical Operations to optimize data flow, risk-based data review, and study execution.
- Ensure inspection readiness and lead responses to regulatory audits and inspections.
- Lead the development and approval of Statistical Analysis Plans (SAPs), mock shells, and analysis methodologies.
- Oversee statistical programming deliverables, including Tables, Listings, and Figures (TLFs).
- Review and interpret study results to support internal decision-making, publications, and regulatory filings.
- Ensure consistency and quality across integrated analyses, ISS/ISE, and submission datasets.
- Provide biometrics leadership for INDs, NDAs, BLAs, MAAs, and other global regulatory submissions.
- Support interactions with regulatory agencies, including briefing documents, responses to information requests, and advisory committee meetings.
- Collaborate with Regulatory Affairs to ensure alignment with evolving regulatory guidance.
- Select, oversee, and manage CROs and external vendors providing data management and biostatistical services.
- Lead vendor oversight governance, performance metrics, timelines, and budgets; Build, develop, and retain a high-performing internal biometrics team.
- Ensure adherence to GxP, ICH E6/E9, 21 CFR Part 11, and data integrity standards.
- Drive continuous process improvements, including risk-based approaches and automation.
- Evaluate and implement innovative analytics approaches, real-world evidence integration, and emerging technologies.
Additional Responsibilities:
