Senior Manager, Biostatistics

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About the 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   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 the Senior Manager, Biostatistics, you will provide strategic and operational statistical leadership for clinical development programs within the Inflammation Therapeutic Area. You will represent Biostatistics at study management team and development team for multiple studies or programs, collaborate closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, Clinical Data Management to ensure high quality statistical planning, analysis, interpretation, and reporting. This may include, but is not limited to, providing statistical strategic input into study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs and CSR review, and providing biostatistical input into scientific publications and presentations, and regulatory requests.  In addition to clinical trials, you may lead or contribute to other activities that are non-molecule based, such as department strategic initiatives or working groups Specific Education & Experience Requirements: • Bachelors degree with 8 years of experience, Masters with 6 years of experience or PhD with 0 years of experience. • 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 manag

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