Principal ADS Program Lead

Responsibilities and Scope

• Guide the technical strategy and operational execution for multiple clinical programs or an entire therapeutic area.
• Lead a team of programmers and junior leaders to deliver high-quality, regulatory‑compliant analytical outputs for key development milestones and health‑authority submissions.
• Oversee day‑to‑day delivery and ensure quality, consistency, and timeliness of analytical deliverables.
• Set priorities, allocate resources, and maintain scalability and sustainability through standardization, automation, and innovation.
• Champion data and programming standards to ensure consistency with enterprise‑wide strategy and regulatory expectations.
• Plan and execute cross‑functional data and analytical deliverables, managing risks and mitigation strategies.
• Act as subject‑matter expert and best‑practice resource within programming, contributing to development of functional standards, tools, and processes.
• Participate in global or complex initiatives, using analytical and programming expertise to solve cross‑study challenges.
• Drive implementation of innovative approaches, including automation or new delivery models, to enhance efficiency and scalability.
• Collaborate across PDD, including Biostatistics, Data Management, and Early Development Biometrics, to integrate analytics strategies into development plans.
• Share knowledge and lessons learned to promote continuous improvement and consistency across programs.
• Mentor less experienced colleagues, fostering best practices in software development, analytics tooling, and scientific collaboration.

• Advanced degree (Master’s or Ph.D.) in Data Science, Statistics, Computer Science, Biomedical Informatics, or related field.
• Minimum of 6 years’ experience in pharmaceutical R&D or a regulated environment with significant exposure to clinical development.
• Demonstrated leadership of molecule‑level analytical strategy or delivery across multiple studies.
• Strong technical expertise in statistical programming (e.g., R, SAS), QC practices, and regulatory data standards (CDISC, ADaM, SDTM).
• Proven ability to manage complex timelines, collaborate across functions, and communicate analytical strategies.
• Experience in vendor oversight and working in matrixed, cross‑functional global teams.
• Independent decision‑making based on sound principles and strategic agility beyond the technical domain.
• Respect for cultural differences and excellent written and verbal communication skills, especially for presentation and reporting.

• Experience leading global submission activities.
• Demonstrated influence in cross‑functional or global team settings.
• Deep knowledge of the drug development lifecycle and analytics’ role at key milestones.

• Expected salary range in Massachusetts: $136,400 – $253,200.
• Actual pay depends on experience, qualifications, location, and other permissible factors.
• Discretionary annual bonus may be available based on performance.
• Eligible for company benefits per policy.
• Relocation benefits are not available for this posting.

Genentech (a member of the Roche group) is an equal‑opportunity employer. The company’s policy prohibits unlawful discrimination and complies with all federal, state, and local laws. Applicants with disabilities should contact the company to discuss accommodations.