Manager, Biostatistics - Inflammation

Location
Foster City, CA
Posted
Jul 21, 2021
Ref
2250981
Required Education
Associate Degree
Position Type
Full time
Manager, Biostatistics - Inflammation
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Manager, Biostatistics - Inflammation

Position Overview:

Biostatisticians at Gilead work 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 Manager, Biostatistics will be primarily responsible for the business, operational, and compliance aspects of Inflammation drug development and marketed product support at Gilead. He/she will support inflammation late stage development in one or more indications.

Key Responsibilities:

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


Education & Experience

  • 4 years + (Bachelors); 0 -2 years (Masters); 0 -2 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 drug development including design and analysis of phase 3 trials and active participation in NDA/BLA filing through label negotiation
  • Demonstrated effective verbal and written communication skills and interpersonal skills are required
  • Examines functional issues from a broader organization perspective
  • Proven ability to determine the functions most critical to company success and to support priorities within functional area
  • Anticipates obstacles and difficulties of clients and acts to meet goals
  • Proven ability to pull together and lead highly effective teams and create a clear sense of direction
  • Proven ability to design and use all available vehicles for effective scientific communication within and outside the company



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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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