Gilead Sciences, Inc.
Director, Statistical Programming
Gilead Sciences, Inc., Raleigh, North Carolina, United States, 27601
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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.
Key Responsibilities
Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers 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.
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.
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.
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.
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.
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.
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.
Qualifications Basic Qualifications
PhD / PharmD and 8 years of experience OR Master’s and 10 years of experience OR Bachelor’s and 12 years of experience
Preferred Qualifications
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.
People Leader Accountabilities
Create Inclusion – model diversity and embed inclusion in team management.
Develop Talent – coach employees on performance and growth.
Empower Teams – align team goals with organizational objectives and remove barriers.
Compensation Bay Area: $210,375.00 – $272,250.00 Raleigh: $181,730.00 – $235,180.00
Benefits include company‑sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, gender identity or expression, veteran status, or the protected characteristics required by law.
Remote Type Remote – Hybrid – Eligible
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Every member of Gilead’s team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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.
Key Responsibilities
Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers 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.
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.
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.
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.
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.
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.
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.
Qualifications Basic Qualifications
PhD / PharmD and 8 years of experience OR Master’s and 10 years of experience OR Bachelor’s and 12 years of experience
Preferred Qualifications
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.
People Leader Accountabilities
Create Inclusion – model diversity and embed inclusion in team management.
Develop Talent – coach employees on performance and growth.
Empower Teams – align team goals with organizational objectives and remove barriers.
Compensation Bay Area: $210,375.00 – $272,250.00 Raleigh: $181,730.00 – $235,180.00
Benefits include company‑sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, gender identity or expression, veteran status, or the protected characteristics required by law.
Remote Type Remote – Hybrid – Eligible
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