Manager, Statistical Programming

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, 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 fulfill their aspirations. Join Gilead and help create possible, together.

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 Manager, Statistical Programming, at Gilead you will ... 

• Exhibit strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.

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

• Review and approve statistical programming requirements (e.g. ADaM Mapping Specifications).

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

• Review and approve key study documents.

• Help statistical programmers understand critical study documents.

• Review statistical programming timelines and negotiate with study team if needed.

• Participate in internal and external audits and identify areas of opportunity to refine and simplify procedural steps.

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

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

• Ensure adequate statistical programming resourcing for study milestones.

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

• Closely monitor and track study statistical programming activities within task management system.

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

• Influence and support data and submission standards, templates, etc.

• Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards.