Manager, Biostatistics

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.

POSITION SUMMARY:

We have a great opportunity to be the statistical lead for multiple clinical trials in either our Seattle or South San Francisco office. This role will work closely with cross-functional teams to ensure appropriate study design, statistical analysis and reporting, and study result interpretation of clinical trials in achieving regulatory, scientific, and business objectives.

KEY ROLE AND RESPONSIBILITIES: 

• Work collaboratively with clinical science, statistical programming, clinical data management, clinical operation, drug safety, translational research, regulatory and project management to meet project deliverables and timelines for statistical data analysis and reporting
• Develop SOPs
• Author statistical sections in protocols, including sample size calculation
• Author statistical analysis plans, mockups, and specification of TLFs for clinical trials
• Apply advanced statistical methodologies to study design and clinical development plan
• Manage vendors and oversee statistical deliverables to ensure the quality of deliverables and ensure the timelines are met
• Perform biomarker and exploratory analyses using advanced statistical methods
• Develop and maintain SAS macros, TLF templates and programming standard
• Review and support the development of CRF design
• Participate, review, and provide statistical input on study documents, such as protocol, IB, DSUR, CSR, etc.

PREFERRED EDUCATION: 

• MBA or MSc in Statistics with a minimum of 8 years’ experience
• PhD with a minimum of 5 years’ experience

PREFERRED EXPERIENCE: 

• Experience in biotechnology or pharmaceutical industry
• Vendor oversight experience
• Demonstrated knowledge and programming skills in SAS and/or R
• Proven experience in oncology (hematology-oncology or solid tumors)
• Exposure to, and experience in machine learning 

KNOWLEDGE, SKILLS AND ABILITIES:

• Solid understanding of overall drug development process and early phase clinical trials
• Strong knowledge and understanding of ICH guidance and GCP standard
• Excellent verbal and written communication skills with the ability to facilitate conversations across teams
• Proven ability to work well in a matrix team environment

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.