Associate Director, Biostatistics
4 weeks ago
United States - New Jersey - Parsippany
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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
Associate Director, Biostatistics
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 Associate 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 clinical 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 oncology clinical trials: developing trial design options and providing high quality decision supportStatistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to Biostatistics function TA leadersWorks collaboratively with Statistical Programmers, Biostatisticians, Clinical Research, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management colleagues to meet project deliverables and timelines for statistical data analysis and reportingDirects 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 performanceIs 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 resourcesLeads one or more components of departmental strategic initiatives
Education & Experience
10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD): 0+ years (MD) 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 oncology trials and active participation in regulatory interactionDemonstrated effective verbal and written communication skills and interpersonal skills are requiredExamines functional issues from a broader organization perspectiveProven ability to determine the functions most critical to company success and to support priorities within functional areaAnticipates obstacles and difficulties of clients and acts to meet goalsProven ability to pull together and lead highly effective teams and create a clear sense of directionProven ability to design and use all available vehicles for effective scientific communication within and outside the company
The salary range for this position is: $173, $225, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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