Associate Director, SDTM Data Standards

Associate Director, SDTM Data Standards
United States – RemoteUnited States - New Jersey - Morris PlainsUnited States - California - Foster CityUnited States - Washington - Seattle

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

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Job Description


The Associate Director of SDTM Data Standards is responsible for driving the data standards and governance of the Gilead clinical data tabulation. This role provides leadership for the continued development and enforcement of data standards, with focus on data tabulation standards, and collaborates extensively with Statistical Programming, as well as various cross-functional groups where needed. In Collaboration with the Data Collection Standards, Data Acquisition Standards, ADaM Standards, and Analysis Planning & Reporting Standards individuals, this role works to implement data standards after an extensive upstream/downstream impact is assessed, maintaining consistency with the other data standard states to ensure accurate and seamless use of end-to-end data standards.

Responsibilities

• Collaborates with Statistical Programming, Clinical Data Management, cross-functional study team members to identify new solutions in data standards that support the scientific need of a study/clinical program and ensures alignment with the data tabulation strategy.
• Consults with Statistical Programming subject matter experts (SMEs) on study team questions related to data tabulation. Facilitates discussions with the SMEs to find solutions that are accurate and timely and can be implemented as data tabulation standards.
• Implements, maintains, and curates new or updated SDTM data standards resulting from discussions with Statistical Programming SMEs.

• Maintains all documentation associated to the SDTM data standards, including but not limited to controlled terminology, implementation guidance, annotated CRF, clinical data study tabulation reviewer's guide templates for various regulatory agencies, and SDTM mapping specifications.
• Regularly meets with Data Collection Standards, Data Acquisition Standards, ADaM Standards, and Analysis Planning & Reporting Standards subject matter experts to create holistic standard solutions for study/project teams while ensuring quality, consistency, and compliance to CDISC standards that supports the exchange of data. Implements future strategies and technology-enable processes and/or tools for the Gilead Clinical Data Standards.
• Maintains common SDTM conformance rules finding explanations. Regularly collaborates with eSUB team and/or the statistical programming study team members to find solutions to SDTM conformance rules findings. Review the SDTM submission packages when needed.
• Serves as a subject matter expert on CDISC SDTM data standards and may serve as subject matter expert on related tools/applications.
• Creates quality control processes, metrics and other measures to ensure compliance with SDTM data standards.
• Promotes tools which help identify when a particular data tabulation module has not followed data tabulation standards.
• Acts as a strong advocate for indication-level tabulation standards development within each therapeutic area.
• Creates any needed documentation and training related to SDTM data standard processes, change control management and tools.
• Assists the Director of Tabulation and Analysis in managing communications on standards updates to Stakeholders.
• Contributes in industry and professional forums discussing the creation and usage of SDTM data tabulation standards.
• Provides leadership through proper guidance and direction to technical individuals, including external vendors or third-party organizations to develop and implement strategies and/or tools.

Qualifications

• 9 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
• 5 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
• 3 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.
• At least 9 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.
• Experience in pharmaceutical industry SDTM data standards management and implementation required.
• Demonstrated experience in all phases of drug development and clinical research in multiple therapeutic areas. Demonstrated knowledge of industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
• Knowledge of SDTM best practices and tools (such metadata repository, global librarian) and has a track record in applying own knowledge to significantly improve efficiencies.
• Ability to work in a fast-paced environment and be influential in reaching prompt decisions to support accelerated clinical trial development.
• Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project timelines and metrics.
• Demonstrated ability establish effective business relationships with external stakeholders.
• Strong problem-solving, verbal and written communication skills; independent and effective working in a multi-disciplinary environment.
• Experience and knowledge in all phases of clinical trials.
• Display aptitude for creativity and innovation.
• Project management, organizational and self-management skills with a focus on results for timeline and accurate completion of competing deliverables.
• Self-motivated to identify and resolve problems with a keen eye on details.
• Proven ability to collaborate in a global environment with colleagues and functional partners across time zones.
• Demonstrated negotiation skills to reconcile differing viewpoints and opinions into actionable decisions.

For Colorado Job Applicants: The salary range for this position is:
$159,040.00 - $238,560.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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