Senior Manager, Statistical Programming – Data Governance Lead
Department: Clinical Development & Clinical Operations
Employment Type: Full-Time / Regular
Location: United States – Remote
Salary Range: $153,935 – $199,210 USD
About Gilead Sciences:
Gilead Sciences is a global biopharmaceutical leader dedicated to advancing therapies that improve and save lives. For over 35 years, Gilead has pioneered treatments in HIV, hepatitis, COVID-19, and cancer, with a mission to address the world’s most significant public health challenges. Our team combines scientific excellence, innovation, and collaboration to deliver meaningful impact for patients worldwide.
Role Overview:
Gilead is seeking a Senior Manager in Statistical Programming to serve as Data Governance Lead. This role will provide leadership and operational expertise to implement a robust data governance strategy, ensuring compliance, consistency, and accessibility of clinical trial and real-world evidence (RWE) data. The successful candidate will align governance practices with corporate objectives, regulatory frameworks, and ethical standards, supporting clinical development and data-driven decision-making.
Key Responsibilities:
Strategy & Leadership
Develop, implement, and maintain a comprehensive data governance strategy for clinical and RWE datasets.
Define governance roles, responsibilities, and operational processes across the data lifecycle.
Ensure adherence to regulatory requirements and industry best practices.
Compliance & Regulatory Alignment
Ensure compliance with EMA Policy 0070, EU CTR, Health Canada PRCI, GDPR, HIPAA, CCPA, and other applicable regulations.
Collaborate with regulatory, legal, and clinical teams to translate requirements into policies, SOPs, and workflows.
Data Access & Sharing
Manage internal and external data sharing, including anonymization, DUAs, and risk-based reviews.
Oversee data request processes, ensuring transparency, traceability, and adherence to FAIR principles.
Implement industry best practices from TransCelerate, PhUSE, and other relevant initiatives.
Operational Oversight
Partner with clinical data and IT teams to embed governance in operational workflows.
Define standards for data retention, archival, anonymization, and re-identification risk mitigation.
Support due diligence for third-party data vendors and clinical data platforms.
Technology & Innovation
Evaluate and optimize governance tools and platforms, including Collibra, Informatica, CPRD, and Aetion.
Promote interoperability and standards such as CDISC, OMOP, and HL7 FHIR.
Develop portals, wikis, and resources to support training and knowledge dissemination.
Basic Qualifications:
Bachelor’s Degree with 8+ years’ experience, OR Master’s Degree with 6+ years’ experience, OR PhD/PharmD with 2+ years’ experience.
Strong leadership, collaboration, and communication skills.
Strategic mindset with execution focus and commitment to ethical data stewardship.
Preferred Qualifications:
6+ years in pharma, biotech, or medical research.
4+ years’ experience working with clinical or RWE data.
2+ years’ experience in data governance, clinical data management, or RWE leadership.
Proficiency in programming languages (SAS, R, Python, MATLAB, SQL).
Familiarity with Smartsheet, Azure DevOps, or MS PowerApps.
Knowledge of data privacy regulations, anonymization techniques, and governance tools.
People Leader Accountabilities:
Create Inclusion: Promote diverse and inclusive teams.
Develop Talent: Mentor and support employees’ professional growth.
Empower Teams: Align teams with organizational objectives and remove barriers to success.
Compensation & Benefits:
Gilead offers competitive base salaries, discretionary annual bonuses, stock-based incentives, and comprehensive benefits including medical, dental, vision, life insurance, paid time off, and wellness programs. Actual compensation varies by experience, qualifications, and geographic location.
Equal Opportunity Employer:
Gilead is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, disability, veteran status, or other protected characteristics. Reasonable accommodations are available for candidates with disabilities.
Application:
If you are a skilled statistical programming professional with experience in data governance and a passion for advancing clinical research, apply today to join Gilead and contribute to improving global healthcare outcomes.
Job Requisition ID: R0049374
Remote Type: Remote / Flexible
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Siliguri |Illinois :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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