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Director Biometrics Jobs (NOW HIRING)

BioPhase Solutions

Medical Director

San Diego, CA

$350K - $385K/yr

Medical Director -- Early Clinical Development (Oncology/Hematology) Location : San Diego, CA ... Partner closely with preclinical/discovery, biometrics, and operations teams. What you bring * MD ...

Cellectis

Senior Director, Biostatistics

Manhattan, NY · On-site

The Senior Director Biostatistics will partner with other company leaders to design and implement ... Oversee and build the biometrics function, ensuring systems, capabilities, and resources are in ...

Mineralys Therapeutics

Director, Statistical Programming

OR · Remote

$235K - $248K/yr

Director Statistical Programmer The Director Statistical Programing (SP) reports to the SVP, Biometrics and is accountable for the production of SDTM and ADAM datasets and Tables, Listings, and Graph ...

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$31.5K

$166.3K

$262.5K

How much do director biometrics jobs pay per year?

As of Jun 15, 2026, the average yearly pay for director biometrics in the United States is $166,260.00, according to ZipRecruiter salary data. Most workers in this role earn between $120,000.00 and $202,500.00 per year, depending on experience, location, and employer.

What are the typical daily and weekly responsibilities of a Director Biometrics?

A Director Biometrics is responsible for overseeing the design, analysis, and management of clinical trial data, ensuring statistical methodologies meet both scientific and regulatory standards. On a daily basis, they may review statistical analysis plans, mentor biometric staff, and collaborate with clinical and regulatory teams to align on study objectives. Weekly, they often attend strategy meetings, interact with vendors or contract research organizations, and provide guidance on data interpretation for submissions or publications. The role requires strong leadership and the ability to effectively manage multiple projects and timelines to ensure the highest quality data output for drug development. Candidates should be prepared for a dynamic, cross-functional environment that supports both independent initiative and collaborative teamwork.

What are the key skills and qualifications needed to thrive in the Director Biometrics position, and why are they important?

To thrive as a Director Biometrics, you need extensive experience in biostatistics or biometrics, a relevant advanced degree (such as an MS or PhD in statistics, mathematics, or a life science), and a proven record of leadership in clinical research environments. Familiarity with statistical programming languages (e.g., SAS, R), regulatory requirements, and data management systems is essential, alongside certifications such as the Society for Clinical Data Management (SCDM) or similar. Outstanding soft skills like strategic thinking, cross-functional collaboration, and effective communication are crucial for leading teams and working with internal and external stakeholders. These competencies ensure the successful oversight of clinical trial data and statistical analysis—critical for regulatory approvals and advancing clinical development programs.

What is a Director Biometrics job?

A Director of Biometrics is a senior professional responsible for overseeing statistical and data analysis related to clinical trials and drug development. They lead teams of biostatisticians and data scientists to ensure compliance with regulatory guidelines and optimize the design, execution, and interpretation of clinical studies. This role involves collaborating with cross-functional teams, guiding statistical strategy, and supporting regulatory submissions. Strong expertise in biostatistics, programming, and industry regulations is essential for success in this position.

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Director Biometrics jobs near you
Infographic showing various Director Biometrics job openings in the United States as of June 2026, with employment types broken down into 87% Full Time, 11% Part Time, and 2% Contract. Highlights an 88% In-person, 3% Hybrid, and 9% Remote job distribution, with an average salary of $166,260 per year, or $79.9 per hour.
Director, Data Management & Biostatistics

Director, Data Management & Biostatistics

Amneal Pharmaceuticals

Bridgewater, NJ • On-site

$250K - $280K/yr

Full-time

Medical, Retirement

Posted 18 days ago

Amneal Pharmaceuticals rating

7.3

Company rating: 7.3 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

56th of 71 rated pharmaceutical

Job description

Job Description
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:
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.

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