Sr Manager, Statistical Programming jobs in United States
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Gilead Sciences · 2 days ago

Sr Manager, Statistical Programming

Gilead Sciences is dedicated to creating a healthier world and tackling significant health challenges. The Sr Manager, Statistical Programming will lead the implementation of a comprehensive data governance strategy, ensuring data accessibility and compliance while aligning with corporate goals and regulatory requirements.

BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

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
Gather and implement Industry best practices as published by Trancelerate, Phuse and others on data sharing and anonymization
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
Support due diligence for third-party data sources and vendors
Evaluate and support governance technologies (e.g., data catalogs, lineage tools)
Promote FAIR principles and interoperability standards (e.g., CDISC, OMOP, HL7 FHIR)
Develop and maintain request portals and wikis in support of content dissemination and continuous learner
Collaborate with IT and cross-functional teams to modernize governance tools and systems

Qualification

Data governance strategyClinical trial dataRegulatory complianceData privacy lawsProgramming languagesGovernance toolsData sharing governanceLeadership skillsCollaboration skillsCommunication skillsStrategic mindset

Required

Bachelor's Degree and Eight Years' Experience
OR
Masters' Degree and Six Years' Experience
OR
PhD/ PharmD and Two Years' Experience

Preferred

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

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Company

Gilead Sciences

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Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.

H1B Sponsorship

Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)

Funding

Current Stage
Public Company
Total Funding
$4.41B
Key Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B

Leadership Team

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Keeley Wettan
Senior Vice President, Legal
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Patrick Loerch
Senior Vice President, Clinical Data Science
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Company data provided by crunchbase