Dompé · 22 hours ago
Director, Statistical Programming
United States
Full-time
Remote
Director/Executive
$236K/yr - $266K/yr
10+ years expDompé is a company focused on innovative therapies, and they are seeking a Director of Statistical Programming to provide strategic and operational leadership for statistical programming across their clinical development portfolio. This role involves ensuring high-quality delivery of analysis datasets and outputs while driving innovation through automation and advanced analytics.
BiotechnologyHealth Care
Responsibilities
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
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
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
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
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
Qualification
Required
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
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
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
A super cool team who’s excited to transform lives through innovative therapies
Company
Dompé
Dompé is a private, family-owned biopharmaceutical company with more than 130 years of independent history, focused on redefining treatments for ophthalmic, neurological, and pain-related conditions through breakthrough science.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Daniele Rizzo
Head of ICT & Digital Transformation
Gianluca Rossetti
Head of Strategic Planning & Business Development
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