Senior Manager, Technical SME Standards

Gilead Sciences

Senior Manager at Gilead leading Data Standards initiatives, collaborating with cross-functional teams. Ensuring adherence to industry standards and regulatory compliance in clinical data processes.

Posted 6/23/2026full-timeFoster City • California • 🇺🇸 United StatesSenior💰 $169,320 - $219,120 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformPython

About the role

Key responsibilities & impact

Establish tools which showcase end-to-end data lineage and impact assessments for standard objects from data collection through analysis and reporting.
Collaborates with Clinical Data Engineering/Macros, CDS Systems & IT, and various cross-functional teams on testing and implementing technology solutions for standards implementation, automation, or governance management.
Oversees system operations for various platforms (in-house and/or vendor systems), that may include user access management, technical implementation and system usage.
Develops workflows, tools, and reports to facilitate the integration of Rawplus standards (a data normalization layer) between data collection and SDTM.
Assists in the brainstorming, testing, and documentation of tools which automate various components of statistical analysis (e.g. tables, figures, and listings, and SDTM tabulation domains, and ADaM analysis datasets).
Stays informed of emerging technologies that can be adopted by the Data Standards organization to further enhance the implementation, efficiency, and usage of the Gilead clinical data standards.
Pioneer and be engaged in initiatives which accelerate the cleanliness and data review tasks associated and/or dependent within Gilead’s standards library.
Demonstrates understanding of CDISC guidance documents and implementation guides, as well as FDA guidance and other regulations while keeping abreast of industry trends in data mapping, data management, standards compliance methodologies, etc.
Champions Digital Data Flow principles to accelerate automation, reduce manual effort, and digitize clinical trial workflows.

Requirements

What you’ll need

8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent OR 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent OR 2 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent
Demonstrated knowledge of drug development and the biopharmaceutical industry required.
Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements.
Proficient knowledge of current regulatory trends including the global landscape.
Demonstrated knowledge of AI-assisted development, working collaboratively with a team of developers in Github, and R or Python proficiency.
Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project timelines and metrics.
Strong problem-solving, verbal, and written communication skills.
Commitment to learning as AI landscape and tooling evolve.
Illustrates creativity to engineer new methods to improve productivity amongst Clinical Data Standards Management.
Display aptitude for creativity and innovation.
Self-motivated to identify and resolve problems with a keen eye on details.

Benefits

Comp & perks

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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.
Company-sponsored medical, dental, vision, and life insurance plans.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

data lineageimpact assessmentsdata normalizationstatistical analysisSDTMADaMAI-assisted developmentRPythonmetadata management

Soft Skills

problem-solvingverbal communicationwritten communicationcreativityinnovationself-motivatedcollaborationattention to detailproject managementcommitment to learning