Senior Manager, Technical SME Standards

Gilead Sciences

Senior Manager of Standards Technical SME at Gilead focusing on the implementation of data standards and collaboration across teams. Overseeing technology solutions for clinical data engineering and automation initiatives.

Posted 7/14/2026full-timeFoster City • California • 🇺🇸 United StatesSenior💰 $169,320 - $219,120 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Clinical Data Standards Management, including knowledge of CDISC guidelines and FDA regulations, combined with proficiency in data analysis tools such as R and Python. Strong ability to collaborate with cross-functional teams to implement technology solutions and enhance data workflows.

Highest-signal resume keywords

CDISC KnowledgeR ProficiencyPython ProficiencyClinical Research ExperienceData Management Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Lineage ToolsStatistical Analysis AutomationWorkflow DevelopmentImpact AssessmentMetadata ManagementRegulatory ComplianceData NormalizationAI-Assisted DevelopmentProject ManagementTechnical Implementation

Soft Skills

Problem-SolvingVerbal CommunicationWritten CommunicationCreativitySelf-Motivation

Tools & Technologies

GithubClinical Data SystemsStatistical Analysis ToolsAutomation ToolsData Collection Platforms

Industry Keywords

Biopharmaceutical IndustryDrug DevelopmentGCPICHFDA RegulationsData Standards ComplianceEmerging TechnologiesDigital Data Flow Principles

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 6 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 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 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

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