Associate Director, Biostatistics

Gilead Sciences•Foster City, CA

About The Position

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.

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.
Leads 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.