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Director, Statistical Programming
Director, Statistical ProgrammingDompé • San Mateo, CA, US
Director, Statistical Programming

Director, Statistical Programming

Dompé • San Mateo, CA, US
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Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet unsatisfied therapeutic needs.

Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

Position Summary

The Director, Statistical Programming at Dompé provides strategic and operational leadership for statistical programming across Dompé’s clinical development portfolio. This role is accountable for ensuring high-quality, compliant, and timely delivery of analysis datasets, TLFs, and submission-ready outputs through a predominantly outsourced programming model, while maintaining strong internal governance, oversight, and standards adherence. The role also drives innovation through the application of automation, advanced analytics, and emerging AI-enabled capabilities within the Biometrics function.

Key Responsibilities

Strategic Leadership & Governance

  • Provide strategic leadership for statistical programming activities across Dompé clinical studies and programs.
  • Define and implement programming strategies aligned with study objectives, timelines, and Dompé standards.
  • Drive adoption of automation, reusable code frameworks, and AI-assisted programming solutions to improve efficiency, quality, and scalability.
  • Contribute to the development and maintenance of Statistical Programming SOPs, Master Work Instructions, templates, and standards.
  • Serve as the statistical programming representative in cross-functional study teams and governance forums.

Study Delivery & Technical Oversight

  • Oversee end-to-end statistical programming deliverables, including SDTM, ADaM, TLFs, Integrated Analyses, define.xml v2.1 and reviewer guides.
  • Ensure compliance with CDISC standards, regulatory guidance, and Dompé internal expectations.
  • Review and approve CRO programming deliverables.
  • Support database lock, interim and final analyses, CSR development, and regulatory submission / inspection readiness.
  • Provide technical leadership on complex analyses, standards interpretation, and advanced data integration.

    • Vendor Oversight

  • Provide oversight of CROs and programming vendors, including evaluation of automation maturity and technical capabilities.
  • Ensure vendor compliance with Dompé standards and expectations.
  • Identify and mitigate risks related to timelines, quality, or technology.

    • Innovation, Automation & Advanced Analytics

  • Lead initiatives to enhance statistical computing environment (SCE) through automation, macros, and modular programming approaches.
  • Support the use of R and Python for exploratory analyses, data visualization, automation, and advanced analytics, as appropriate and compliant.
  • Partner with Biostatistics, and IT to evaluate and responsibly implement AI / ML-enabled tools for programming productivity, data review, and quality checks.
  • Promote best practices for validation, traceability, and regulatory compliance when using automation or AI-supported solutions.

    • Quality & Compliance

  • Ensure inspection-ready deliverables and documentation.
  • Participate as a subject-matter expert in internal audits, vendor audits, and health authority inspections.
  • Ensure appropriate governance and documentation for statistical programming processes, including automated and AI-assisted processes.
  • Promote a culture of quality, innovation, and continuous improvement.

    • Qualifications

  • Master’s degree or higher in Statistics, Biostatistics, Computer Science, Life Sciences or a related discipline.
  • 10–14+ years of experience in statistical programming within the pharmaceutical, biotech, or CRO industry.
  • Strong hands-on expertise in SAS for clinical trial data analysis and reporting.
  • Working knowledge of R and Python for data analysis, automation, and advanced analytics.
  • Demonstrated experience delivering SDTM, ADaM, and TLFs for Phase I–III clinical studies.
  • Experience operating within outsourced and vendor-heavy programming models.
  • Strong communication, leadership, and problem-solving skills.

    • Preferred Qualifications

  • Experience supporting FDA and / or EMA regulatory submissions.
  • Hands-on experience with define.xml v2.1, reviewer’s guides, and submission packages.
  • Experience with SAS, cloud-based analytics platforms, or modern data environments.
  • Exposure to AI / ML applications in clinical development or data analytics, with a strong understanding of regulatory and validation considerations.

    • BENEFITS OF JOINING OUR TEAM

  • Comprehensive medical benefits : we value access to healthcare for our patients as well as our employees
  • Generous vacation / holiday time off : we care about our employees and encourage a balanced lifestyle
  • Competitive 401(K) matching
  • Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train
  • A super cool team who’s excited to transform lives through innovative therapies

    • $236,000 - 266,000 a year

    At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

    We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines.

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