Description
The Senior Statistical Data 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 a Director 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.
Responsibilities
- 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 which includes study level or integrated analysis for safety signal detection or other business needs
- 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.
Qualifications
- 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 5+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred
- Programming experience in SAS a must. Experience working with other languages (R) 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
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This role can be based at our Hayward, CA (or Brisbane, CA) location (preferred) or remote-based. The salary range for this position onsite in one of our CA offices is $140,000-$155,000. For remote-based candidates, the salary range will be based on the local market, which can vary from state to state. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers/
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets