Principal Statistical Data Analyst
Arcus Biosciences, Inc.
Hayward, California, United States
Job type: fulltime
Job industry: I.T. & Communications
Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.
We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written.
The Principal Statistical Programmer Analyst will be responsible for the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming infrastructure. This position will report into the Head of Statistical Programming and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.
This is an unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work.
- Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review
- Adopts strategic approach to producing and prioritizing analytical deliverables, incorporating innovative tools and methods where needed (pipelines, visualizations, dashboards via tools like Spotfire, Tableau, R-Shiny or similar)
- Work with data management to review case report forms, database specifications, and data transfer specifications
- Manage on-time and quality delivery of CRO-generated analyses results
- Solid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements
- In-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data types
- Performs stakeholder management, negotiating timelines and scope of deliverables (helping to balance team and company needs with speed, rigor and clarity of message)
- Provides leadership or project management to major data-heavy study or project team deliverables or initiatives
- Participate in standards governance and developing biometric department operational processes.
- Work with the Head of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
Qualifications (including knowledge & skills):
- Bachelor's or Master's degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
- Minimum 7+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred
- Programming experience in SAS is a must. Experience working with other languages or software (R, Python, Spotfire) in validated environments strongly preferred
- In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, real-world, etc.)
- Experience managing delivery of statistical programming projects by CROs
- Demonstrated ability to rapidly adapt to changing project and strategic requirements
- Interest in continuing education, particularly in the areas of business knowledge as well as technology trends for producing analyses and visualizations (particularly with an eye towards reproducibility or interactivity)
- Takes a fit-for-purpose mindset to daily work as well as long-term vision