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:
QualificationsEducation:
- Master Degree (MS/MA) Biostatistics, Statistics, Mathematics, Epidemiology, or a related scientific discipline - Required
Experience:
- 10 years or more in progressive experience in data management and biostatistics within the pharmaceutical or biotech industry.
- 5 years or more in leadership role managing teams and/or CROs.
- in Direct experience supporting Phase I–IV clinical trials and global regulatory submissions.
- in Experience with CNS, oncology, rare disease, or complex adaptive trial designs
- in Exposure to real-world evidence (RWE) and post-marketing studies
- in Experience leading successful regulatory inspections and audits
Specialized Knowledge:
- Deep knowledge of CDISC standards (SDTM, ADaM), SAP development, and regulatory expectations
- Hands-on experience with statistical software (e.g., SAS; R preferred)
- Strong understanding of FDA, EMA, ICH (E3, E6, E9, E17), and GxP requirements
- Proven ability to lead cross-functional teams in a matrixed pharmaceutical environment and/or teams at external vendors/CROs
- Excellent written and verbal communication skills, including the ability to present complex statistical concepts to non-technical audiences
- Demonstrated ability to influence senior stakeholders and contribute to strategic decision-making
The base salary for this position ranges from $250,000 to $280,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
