Senior Manager, Biostatistics

Gilead Sciences•Parsippany, NJ

7d•$153,935 - $219,120

About The Position

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.

Requirements

PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment. PhD with 4+ years’ biostatistics experience is preferred.
MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
BA/BS in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams.
Significant biomedical statistical analysis experience and experience working with relevant software.
Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics.
Proven effectiveness managing projects and teams.
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Has advanced knowledge of underlying statistical principles, concepts, practices, standards, processes and tools, and has shown ability to effectively apply this knowledge to achieve targeted outcomes to meet business needs.

Nice To Haves

PhD with 4+ years’ biostatistics experience is preferred.

Responsibilities

With guidance, acts as biostatistics lead on clinical studies or other non-molecule projects.
Where applicable and with guidance, leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross-functional partners.
Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans.
Typically assigned clinical studies or other projects of increasing complexity or size.
Depending on area of assignment, may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
Where applicable, oversees and contributes to completion of all technical and operational statistical activities for a group of clinical trials.
Directs internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products of increasing complexity.
Where applicable, participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input.
Where applicable, participates in cross-functional protocol design and review discussions.
Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
Leads the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products.
Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry.
Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools.
Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
May participate in or lead special projects that can benefit multiple Biostatistics team members, such as new methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
Provides matrix management to projects supported.
Independently defines required resources for assigned work, seeking advice as needed.
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.