Associate Director, Biostatistics

Gilead Sciences•Foster City, CA

6d•$195,670 - $253,220•Onsite

About The Position

At Gilead, we are dedicated to creating a healthier world for all people. For over 35 years, we have been at the forefront of tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer, relentlessly developing therapies to improve lives and ensure global access. Our mission requires collaboration, determination, and a drive to make a difference. Every employee plays a crucial role in discovering and developing life-changing scientific innovations. We are seeking passionate and ambitious individuals ready to make a direct impact. As a people leader at Gilead and Kite, you are essential in evolving our culture and creating an inclusive environment where employees feel developed and empowered to achieve their aspirations. Join Gilead to help create what's possible, together. In this role, you will provide strategic and operational statistical leadership for clinical development programs within the Inflammation Therapeutic Area. You will represent Biostatistics on study management and development teams for multiple studies or programs. Your responsibilities will include collaborating closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, and Clinical Data Management to ensure high-quality statistical planning, analysis, interpretation, and reporting. This involves providing statistical strategic input into study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs and CSR review, and contributing to scientific publications, presentations, and regulatory requests. Beyond clinical trials, you may also lead or contribute to non-molecule-based activities, such as departmental strategic initiatives or working groups.

Requirements

Bachelors degree with 10 years of experience, Masters with 8 years of experience or PhD with 2 years of experience.
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.

Responsibilities

Provide strategic and operational statistical leadership for clinical development programs within the Inflammation Therapeutic Area.
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.
Provide statistical strategic input into study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs and CSR review.
Provide biostatistical input into scientific publications and presentations, and regulatory requests.
Lead or contribute to other activities that are non-molecule based, such as department strategic initiatives or working groups.
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.
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.
Lead two or more components of departmental strategic initiatives.
Create Inclusion - knowing the 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 employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.