Director, Biostatistics

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
 

Job Description – Director, Biostatistics-Oncology  

Position Overview: 

The Biostatistics function at Gilead works collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives. The Director will be primarily responsible for the business, operational, and compliance aspects of Oncology drug discovery, development, and marketed products at Gilead. He/she will support oncology late-stage development, working collaboratively for the development plans, regulatory interactions, and HTA/commercial evaluation of a Gilead Oncology compound in one or more indications. 

Key Responsibilities:  

• Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support. 

• Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head 

• Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting 

• Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance 

• Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources 

• Leads two or more components of departmental strategic initiatives 

Education & Experience :  

• 12 years + (Bachelors); 10+ years (Masters); 8+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO) 

• Industry experience in the statistical analysis of biomedical data using statistical software 
  Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation 

• Demonstrated effective verbal and written communication skills and interpersonal skills are required 

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