Director, Biostatistics

Gilead Sciences•Foster City, CA

About The Position

The Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead. He/she will support Virology drug development, working collaboratively for the development plans, regulatory interactions, and commercial evaluation of a Gilead Virology compound in one or more indications. As a Director of Biostatistics at Gilead, you will provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support. You will be the Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head. You will work collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting. You will use your knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives. You will collaborate with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company. You will negotiate project timelines given constraints, work with senior management and Human Resources to identify long-term staffing plans, provide career development opportunities to staff, and participate in strategic risk assessment based on statistical analyses or principles. You are expected to oversee and contribute to the completion of all technical and operational statistical activities for multiple development programs for a compound or equivalent through management of internal and external resources. You will provide overall leadership for a departmental strategic initiative with experience directly supervising personnel.

Requirements

PhD with 8+ years of industry experience OR Masters degree with 10+ years of experience or Bachelors degree with 14+ years of experience
Excellent verbal and written communication skills and interpersonal skills

Nice To Haves

Industry experience in the statistical analysis of biomedical data using statistical software (SAS and R experience preferred)
Extensive hands-on experience in drug development including design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation
Effective verbal and written communication skills with the ability to convey complex concepts in clear, concise, and accessible language
Strong collaboration and interpersonal skills with demonstrated success in fostering effective relationships and working seamlessly within diverse cross-functional team
Adept at analyzing challenges from a holistic, cross-functional viewpoint to align with broader organizational or project goals
Anticipates obstacles and understands stakeholder needs to proactively develop and implement practical and effective solutions
Demonstrated ability to assemble and lead high-performing teams, providing clear direction and fostering a shared vision for success

Responsibilities

Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support.
Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
Works collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives.
Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company.
Negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles.
Oversee and contribute to the completion of all technical and operational statistical activities for multiple development programs for a compound or equivalent through management of internal and external resources.
Provides overall leadership for a departmental strategic initiative with experience directly supervising personnel.
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.