Senior Manager, Technical SME Standards

Gilead Sciences•Foster City, CA

2d•$153,935 - $219,120•Onsite

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager of Standards Technical SME, you are responsible for serving as the liaison for the Data Standards organization with the Clinical Data Engineering/Macros, CDS Systems & IT, and other internal and external stakeholders associated with IT applications, platforms and automation tools related to the implementation and enhancement of data standards. This position facilitates the development of programs and codebases to support the vision of the Data Standards team. Candidates able to sit at our Foster City, CA campus are preferred and will be prioritized.

Requirements

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.
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
Experience required: experience in multiple phases in clinical trials in more than one therapeutic area, with experience in development of clinical data pipelines or working with end-to-end data standards or generation of data submission packages.

Nice To Haves

Demonstrated ability to establish effective business relationships with external stakeholders and vendors preferred.

Responsibilities

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.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.