Director, Statistical Programming
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.
You will oversee all Statistical Programming activities to support multiple drug development programs. The position requires a broad understanding of the drug development processes and regulations, comprehensive knowledge of SAS and CDISC standards, regulatory filing experience and CRO management experience. You will work closely with cross-functional teams including biostatistics, clinical operation, clinical science, data management, safety science and translational research. This role may sit either in our South San Francisco or Seattle office.
KEY ROLE AND RESPONSIBILITIES:
- Lead the Statistical Programming function for high-quality and on-time deliverables of clinical trials.
- Develop and implement Statistical Programming SOPs and work instructions.
- Oversee the process to identify, evaluate and select CROs for Statistical Programming activities.
- Manage vendors and oversee Statistical Programming deliverables to ensure the quality of deliverables and ensure the timelines are met.
- Recruit, manage and mentor Statistical Programming FTEs and/or contractors.
- Serve as the lead statistical programmer for clinical trials and work closely with cross-functional teams to ensure compliance with regulations, policies, procedures, and clinical objectives.
- Manage budget and resource planning across multiple projects.
- Develop and maintain CDISC-compliant and submission-ready SAS programs, CDISC data sets and Tables/Figures/Listings.
- Develop and maintain SAS macros, TFL templates and programming standard.
- Review and support the development of SAP and CRF design.
- Work with the Information Sciences team to set up and maintain computing infrastructure/environment.
- Bachelor/Master’s degree in Statistics, Mathematics, Computer Science, or other close-related fields
- Minimum 12 years of statistical programming experience in biotechnology or pharmaceutical industry, with vendor oversight experience.
- At least 5 years management experience.
- Experience with complex clinical trials in oncology (hematology-oncology or solid tumors) is required.
- Extensive experience with CDISC standard.
- Experience with NDA/BLA filing(s).
- Additional experience with cell therapies; exploratory data analysis and/or statistical software other than SAS (e.g. R) is a plus.
KNOWLEDGE, SKILLS AND ABILITIES:
- Advanced knowledge and experience of Statistical Programming processes and computing systems.
- Solid understanding of overall drug development process and early phase clinical trials.
- Solid 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.
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.