Director, Data Management & Biostatistics

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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:

Qualifications Education:

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. Required Skills Budgeting Detail Oriented Good Clinical Practices (GCP) ICH Guidelines Interpersonal Communications Negotiation Project Planning Regulatory Requirements Resource Planning Risk Management Writing Apply Now Job Info Job Identification 7815 Job Category Clinical Trial Management Posting Date 04/28/2026, 03:15 PM Locations 400 Crossing Blvd, Bridgewater, NJ, 08807, US Degree Level Master's Degree Job Schedule Full time © MapTiler © OpenStreetMap contributors Legend Jobs at a location Group of locations © MapTiler © OpenStreetMap contributors | © Oracle Corporation Terms Legal Notices Use control and scroll to zoom the map Use two fingers to move the map 400 Crossing Blvd, Bridgewater, NJ, 08807, US Copy to Clipboard Similar Jobs Data Reviewer-Senior Scientist, Quality Control Piscataway, NJ, United States Posted on 04/15/2026 Trending The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Medical Affairs Director - Parkinson's Disease and Movement Disorders Bridgewater, NJ, United States Posted on 04/07/2026 2026 Summer Internship - Data Analytics (Biosimilars) Bridgewater, NJ Bridgewater, NJ, United States Posted on 04/27/2026 Trending Amneal is seeking a detail-oriented Quality Control Intern to support analytical laboratory operations. This internship is ideal for a Pharmacy or Chemistry student interested in quality control testing, sample handling, documentation, and GMP-compliant lab practices. Position Overview The Quality Control Intern will assist with sample management, document organization, archiving, and routine laboratory support. The intern will gain exposure to analytical QC testing, LIMS, stability studies, data review workflows, metrology activities, and GMP/GLP requirements. Associate Director, Corporate Counsel Bridgewater, NJ, United States Posted on 04/20/2026 The Commercial Counsel will be an integral member of the Amneal Legal team and will serve as a trusted legal advisor for all commercial activities and will serve as a member of Amneal's promotional assets review committee (PARC). See More Jobs