Director, Statistical Programming
About The Position
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Director, Clinical Data Science – SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of Statistical Programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role owns a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services.
Requirements
- PhD / PharmD and 8 years of experience OR Master’s and 10 years of experience OR Bachelor’s and 12 years of experience
Nice To Haves
- Education: BS/MS/PhD in Biostatistics, Computer Science, or related field; advanced degree preferred.
- Technical Skills: Expert in SAS Macros and strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud.
- Core Competencies: Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering.
Responsibilities
- Strategic Leadership & Team Management Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions.
- Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team.
- Programming Oversight & Technical Excellence Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs).
- Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness.
- Promote automation and standardization of programming workflows to improve efficiency and consistency across studies.
- Project Delivery & Resource Management Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization.
- Manage project timelines, budgets, and external vendor relationships as needed.
- Cross-Functional Collaboration Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity.
- Represent the statistical programming function in cross-functional meetings and strategic initiatives.
- Process Optimization & Innovation Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality.
- Evaluate and integrate emerging technologies into statistical programming workflows.
- Compliance, Documentation & Quality Assurance Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables.
- Oversee code quality, version control, and documentation governance frameworks.
- Stakeholder Engagement & Training Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders.
- Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables.
Benefits
- This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
- For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
