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.
The Biostatistics function at Gilead works 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 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 late-stage 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 late-stage oncology clinical trials: developing trial design options and providing high quality decision support.
- Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
- 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
Qualifications & Experience:
- 12 years + (Bachelors); 10+ years (Masters); 8+ 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 oncology drug development including design and analysis of phase 3 oncology 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
People Leader Accountabilities:
- 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.
