Senior Manager, Technical SME Standards

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 y

Benefits

Additional Information

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description 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. Specific Job 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.

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