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).
Job Summary:
The Director, Biostatistics provides enterprise-level statistical leadership and strategic direction for clinical development programs across multiple therapeutic areas. This role is accountable for defining and executing the biostatistics strategy, ensuring scientific excellence, regulatory compliance, and strong cross-functional integration, while leading and developing the biostatistics organization to support the company’s pipeline and long-term objectives.
Essential Funtions:
● Define and drive the overall biostatistics strategy for clinical development programs, ensuring alignment with corporate, scientific, and regulatory objectives across early- and late-phase trials.
● Serve as the senior Biostatistics and Biometrics leader on key development programs, with accountability for program-level decision making and oversight of Biostatistics, Statistical Programming, and Data Management strategies and resourcing.
● Lead the evaluation, selection, and strategic management of CRO partners, ensuring high-quality deliverables, effective governance models, and optimal outsourcing strategies.
● Provide senior-level collaboration with Clinical Development, Regulatory Affairs, Medical Writing, Data Management, and Statistical Programming to ensure integrated development plans and robust statistical analysis strategies.
● Accountable for the scientific integrity, quality, and consistency of all statistical contributions to clinical protocols, Statistical Analysis Plans, Clinical Study Reports (CSRs), regulatory submissions, and other key development documents.
● Establish and maintain governance, quality standards, and best practices for statistical methodologies, deliverables, and review processes across the organization.
● Serve as the primary senior statistical representative in interactions with regulatory authorities (e.g., FDA, EMA), providing strategic leadership during regulatory meetings, submissions, and advisory interactions.
● Provide strategic oversight and final scientific review for statistical contributions to scientific publications, congress presentations, and external communications.
● Lead, mentor, and develop the biostatistics organization, including performance management, succession planning, talent development, and fostering a culture of scientific rigor, innovation, and continuous improvement.
● Monitor emerging statistical methodologies, regulatory guidance, and industry trends, translating innovation into actionable strategies that enhance development efficiency and scientific impact.
Education & Experience:
● PhD or Master’s degree in Biostatistics, Statistics, or a related quantitative discipline.
● Minimum of 10 years of progressive experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry, including demonstrated leadership of teams and/or functions.
● Extensive experience providing senior statistical leadership across multiple clinical development programs and therapeutic areas.
● Extensive track record of senior statistical leadership in clinical development, including successful leadership of major regulatory submissions and interactions with global health authorities (e.g., FDA, EMA).
● Strong working knowledge of statistical programming environments (e.g., SAS and/or R), with the ability to provide strategic oversight as well as hands-on programming.
● Deep expertise in innovative clinical trial designs, including adaptive designs, Bayesian methods, and other advanced statistical methodologies.
● Advanced knowledge of productivity, collaboration, and data review tools (e.g., MS Office and related platforms).
● Exceptional leadership, communication, influencing, and organizational skills, with the ability to engage and advise senior internal and external stakeholders.
● Demonstrated ability to lead complex, cross-functional programs and manage competing priorities at a portfolio level in a fast-paced environment.
BENEFITS OF JOINING OUR TEAM
Salary Range: $227,000 - $259,000
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.