Analysis Oversight Statistical Programming Lead- Manager

About this role

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   Clinical Data Science (CDS) is a business unit within Development whose mission is to achieve regulatory approval and successful marketing of new therapies through a reproducible, transparent, efficient, and validated approach to study design, data acquisition, analysis, and interpretation. Our pursuit is to deliver on unmet medical needs by introducing therapies for life-threatening diseases. Within CDS, we strive to reach this goal through excellence in data management, analytical methods, and advanced programmatic approaches to gain insights from a wide range of data assets.

To achieve the commitments of our clinical portfolio, CDS has been developing an agile and sustainable resource model that leverages external partnerships to form a strong alliance with internal Gilead roles. Together, these teams will deliver statistical programming outputs that meet study analysis needs and requirements. The Analysis Oversight Statistical Programming (AOSP) Lead is essential to these partnerships. As a member of the Study Management Team (SMT), the AOSP Lead works closely with the study team to determine the statistical programming requirements, understand study milestones and programming dependencies, and leads the development of the programming outputs.

The Analysis Oversight Statistical Programming Lead is accountable for the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables, ensuring completeness, accuracy, and compliance with regulatory and quality standards. This role will progressively review vendor performance metrics in governance meetings to monitor trends and address any challenges, risks, and/or bottlenecks encountered by the study programming team.

The position requires a strong acumen in statistical analysis, focused on achieving high-quality outputs that support clinical results. In addition, the candidate will need to perform quality management, coach and mentor programming colleagues, and provide statistical guidance as it relates to specifics of the study and general processes and statistical program education. The candidate will need to closely monitor the quality and timeliness of clinical trial programming deliverables, provide process guidance, support creation and maintenance of onboarding materials, and direct prioritization and coordination of study related deliverables.

Key Responsibilities will include, but are not limited to the following: • Exhibits strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.

• Attends SMT Meetings, providing functional input on programming related activities and potential risks.

• Reviews and approves statistical programming requirements (e.g. ADaM Mapping Specifications).

• Communicates SMT decisions, discussions, and action items to statistical programmers.

• Reviews and approves key study documents.

• Helps statistical programmers understand critical study documents.

• Reviews statistical programming timelines and negotiates with study team if needed.

• Participates in internal and external audits and identifies areas of opportunity to refine and simplify procedural steps.

• Analyse vendor performance through assessment of Key Performance and Quality Indicators (e.g. KPI, KQI), metrics, and results.

• Participates as needed in vendor governance discussions to address any performance related risks and/or concerns.

• Ensures adequate statistical programming resourcing for study milestones.

• Assigns tasks to statistical programmers based on experience and ability.

• Closely monitors and tracks study statistical programming activities within task management system.

• Maintains regular communications on study statistical programming milestone activities with appropriate study team members and stakeholders.

• Influences and supports data and submission standards, templates, etc.

• Performs quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards. • Ensures programming activities are executed in correct order.

• Ensures validation documentation, folder locking, and TMF requirements are observed.

• Surfaces the need for new or updated standards to improve efficiency and uniformity across TA or Indication level objects.

• Provides prioritization decisions and coaching to fellow onboarding staff as needed to advance their knowledge on Gilead processes and statistical programs & methods.

• Ensures the programming team identifies data issues and enters accordingly into the Data Issue Log. In addition, ensures all issues and observations noted on the issue log have been resolved prior to final production release.

• Holds analysis team meetings with Biostatisticians.

• Serves as the

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