About Dompe
Ciao! At Dompé, our success is rooted in our team and our history. We are a private, rapidly growing global pharmaceutical company. Founded in Milan, Italy, we have a 130-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States. Today Dompé has over 900 employees worldwide with our R&D hub based in Boston, and Commercial organization centered in the San Francisco Bay Area.
Position Summary
The Sr. Director, Statistical Programming & Data Management is a development leadership role which involves planning, implementation and maintenance of a statistical programming environment, data management systems and repository; oversight of the statistical programming and data management activities to support clinical trials, regulatory submissions, and drug development processes at the highest level. The ideal candidate will possess exceptional leadership abilities, extensive technical expertise, and a comprehensive understanding of regulatory requirements and industry standards. This individual will report to the Vice President, Biometrics.
Key Responsibilities
• Planning, implementation and maintenance of a statistical programming environment, data management systems and data repository
• Leadership and Strategic Management: Develop and provide leadership and strategic direction for the Statistical Programming and Data Management functions, ensuring alignment with the overall business objectives and goals of the company.
• Program Development: Develop and implement advanced statistical programming strategies and processes, optimizing productivity, quality, and innovation in deliverables.
• Collaboration: Foster strong working relationships with executive leadership, clinical research and operations, biostatistics, and regulatory teams to ensure seamless integration and execution of programming and data management activities.
• Regulatory Compliance: Oversee internal and external programming and data management activities to ensure compliance with regulatory requirements, industry standards, and company policies.
• Resource Allocation: Strategically manage resource allocation and budgeting for statistical programming and data management projects, ensuring optimal use of company resources.
• Training and Development: Lead initiatives to mentor and develop Programming and Data Management staff, promoting a culture of continuous learning, growth, and improvement.
• Quality Control: Establish and oversee robust quality control processes for programming and data management deliverables, ensuring accuracy, consistency, and adherence to the highest standards. Develop and implement robust strategies to ensure the integrity, accuracy, and security of all clinical data.
• Documentation: Ensure comprehensive documentation of programming and data management processes, methodologies, and outputs, maintaining transparency and rigor.
• Innovation: Identify and implement cutting-edge solutions to enhance programming and data management efficiency and effectiveness, driving innovation within the department.
Basic Qualifications
• Bachelor’s degree in statistics, mathematics, computer science, engineering, life sciences or related field
• 12 or more years of experience in statistical programming and data management within in the bio/pharma industry
• Expert knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC standards (SDTM, ADaM)
• Familiarity with data visualization tools
• In-depth understanding of the drug development process, including experience with regulatory filings, and Comprehensive understanding of FDA, EMA, and ICH guidelines related to statistical programming and data mangement.
• Leadership Abilities: Proven ability to lead and manage diverse teams, with excellent interpersonal and communication skills.
• Ability to communicate clearly both oral and written.
• Proven ability to manage consultants, vendors and contracts.
• Excellent communication, presentation, and organizational skills.
• Empathetic and collaborative team player with a proactive, solutions-oriented mindset.
• Strong business acumen, with the ability to balance patient needs with organizational goals.
• Ability to travel approximately 15-20% of the time.
Preferred Qualifications
• Master’s Degree or similar advanced technical degree preferred
• 15 or more years of experience
Location: Remote
Base Salary: $250,000 - $280,000 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.
