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 science. We are a learning organization dependent on deep collaborative relationships between our colleagues, partners, and founders. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are and the environment we create. The following role can be based out of our California or Washington offices.
The Statistical Programming Associate Director is responsible for the quality, timely and efficient delivery of project statistical programming outputs. This position requires considerable programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. The primary role of this position is to act as a lead statistical programmer and project manager for the studies and programs in the Biometrics team and interact with other stakeholders in a study or product team.
Job Responsibilities:
- The Statistical Programming Associate Director is accountable for the quality, timely and efficient delivery of project programming work with good quality
- Oversees and manages external vendors to ensure high-quality deliverables and manage timelines for the outsourced deliverables
- Develops and validates standard department/generic macros and template programs
- Effectively manages, develops, and reviews the analysis datasets, TLF’s, and other deliverables as required
- Provides expert-level hands-on support for the statistical programming deliverables including but not limited to the regulatory, publication, Adhoc requests, post-hoc, and exploratory data analyses
- Leads and directs the full scope of project delivery and/or leads a technical project within the drug product/study/function
- Leads Implementation of statistical programming aspects of the protocol or clinical development program
- Leads or contributes to cross-functional administrative or process improvement initiative(s)
- Participates in the development, maintenance, and adherence to departmental SOPs and Guidelines
- Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function
- Drives or supports standards development and implementation in statistical programming function
- Manages and escalates risk in complicated situations within their study and/or projects
- Provides input and/or drives improvement of processes and programming implementation.
- Maintains expertise in the latest industry and regulatory requirements to stay current
- Manages and is willing to coach and mentor junior or contract programmers
- Lead the projects for the programming deliverables and milestones from study start-up to regulatory submission
- Work with the study, product, and biometrics team in goal and timeline setting
- Develop or review technical programming specifications and programs, and generation of SDTM and ADaM datasets, Tables, Listings, and Graphs
- Support, validate, and maintain programming infrastructure and standard department macros and template programs to ensure high-quality and efficient deliverables
- Review documents for submission readiness and conformity to company and health authority guidelines eg SDSP, ADRG, cSDRG
Qualifications
- This position requires extensive programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers
- Bachelor’s or master’s degree in Statistics or Mathematics, Computer Sciences, IT, or related fields
- Minimum of 6 years experience in the Pharmaceutical Industry, or relevant Regulatory environment
- Thorough knowledge of CDISC SDTM, ADaM, Define.xml, and other industry standards, and ability to implement the standards
- Strong knowledge of the clinical development process, GCP/ICH standards, and global regulatory submission requirements
- Working knowledge of current regulations, familiarity with eCTD format and content of regulatory filings with prior experience filing a BLA/MAA/NDA
- Current knowledge of technical and regulatory requirements relevant to the statistical programming role
- Ability to apply programming expertise to problem-solving and troubleshooting for teams
- Proven ability to operate with limited oversight
- Ability to effectively manage multiple tasks and projects. Demonstrate planning and project management skills
- Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures
- Experience in working with an outsourced model
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.
The salary range for this position is $190,000 and $205,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
Our Employee Benefits program is extensive and includes subsidized medical, dental, and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 days’ sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found here.
At Lyell, we believe that the 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 against 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.
