Associate Director, Biostatistics

Biopharma Careers; Foster City (CA); On-site; USD 196,000 - 253,000; Full time

Job summary

Gilead Sciences Inc. is seeking an Associate Director of Biostatistics to lead statistical strategy for inflammation-focused clinical programs.

You will partner with study teams and cross-functional groups to ensure rigorous analysis, interpretation, and reporting throughout development and regulatory processes. The role requires leadership in study design, protocol development, and statistical reporting, with responsibilities spanning TFLs, CSRs, SAPs, and publications.

Qualifications

• Bachelor's degree with 10 years of experience, Masters with 8 years or PhD with 2 years (as stated).
• Works with Statistical Programmers, Biostatisticians, Clinical Research staff to meet deliverables.

Responsibilities

• Provide strategic and operational statistical leadership for clinical development programs in the Inflammation Therapeutic Area.
• Represent Biostatistics at study management and development teams; collaborate with Clinical Development, Patient Safety, Regulatory Affairs, and other functions.
• Lead or contribute to statistical input into study design, SAP, CSRs, and regulatory submissions; support publications and presentations.

Skills

Statistical leadership

Cross-functional collaboration

Verbal & written communication

Regulatory collaboration

Education

Bachelor's degree (relevant field)

Job description

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

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 Associate Director, 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 10 years of experience, Masters with 8 years of experience or PhD with 2 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 management of internal and external resources.
• Leads two or more components of departmental strategic initiatives.
• Excellent 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.
• Must be able to directly supervise personnel.

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $195,670.00 - $253,220.00. 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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 [e-mail] for assistance.

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