
Senior Manager, Statistical Programming
Gilead Sciences
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $153,935 - $199,210 per year
Job Level
Senior
Tech Stack
AzureInformaticaPythonSQL
About the role
- lead the implementation of a comprehensive data governance strategy that ensures data accessibility, compliance to regulations and contracts, and ensure consistency of governance practices across clinical trial and real-world evidence (RWE) data
- Develop and execute a data governance strategy for clinical trial and RWE data
- Maintain and improve governance processes and procedures
- Ensure governance roles and models are appropriate across the data lifecycle
- Ensure proper adherence and compliance to all applicable regulations Including: EMA Policy 0070: Anonymization and redaction of CSRs, Health Canada PRCI and EU CTR: Transparency and data sharing mandates, Data privacy laws (GDPR, HIPAA, CCPA): Including cross-border data transfers
- Collaborate with CDS, Regulatory, and Legal teams to translate regulations into policies and SOPs
- Oversee internal and external data sharing governance: Maintain anonymization algorithms and methodologies, Manage data requests for licensed RWE and clinical trial data, Support DUAs, data sharing committees, and risk-based reviews, Ensure transparency and traceability in data sharing decisions
- Partner with CDS and Gilead Data Office to embed governance in operations.
- Define governance roles for: Data retention, destruction, and archival, Anonymization standards and re-identification risk mitigation
- Evaluate and support governance technologies (e.g., data catalogs, lineage tools)
Requirements
- Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD/PharmD and Two Years' Experience
- 6+ years in pharma, biotech, or medical research
- 4+ years working with data
- 2+ years in data governance, clinical data management, or RWE leadership
- Proficiency in a programming language such as MATLAB, SAS, R, Python, or SQL
- Intermediate skills in Smartsheet, Azure DevOps, or MS PowerApps
- Understanding of clinical and RWE data structures, regulatory frameworks, and privacy laws
- Familiarity with EMA Policy 0070, EU CTR, GDPR, HIPAA, and anonymization techniques
- Experience with governance tools (e.g., Collibra, Informatica) and data platforms (e.g., CPRD, Aetion)
- Strong leadership, collaboration, and communication skills
- Ability to operationalize legal and regulatory requirements
- Strategic mindset with a focus on execution and ethical data stewardship.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans*
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data governanceclinical data managementreal-world evidence (RWE)programming languagesMATLABSASRPythonSQLanonymization techniques
Soft skills
leadershipcollaborationcommunicationstrategic mindsetexecutionethical data stewardship