Senior Statistical Data Analyst

Senior Statistical Data Analyst

Job Title: Senior Statistical Data AnalystLocation: Hayward/Brisbane, CA (Can be remote) 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 to the 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. ResponsibilitiesDevelop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory reviewAdopts strategic approach to producing and prioritizing analytical deliverables which includes study level or integrated analysis for safety signal detection or other business needsWork with data management to review case report forms, database specifications, and data transfer specificationsManage on-time and quality delivery of CRO-generated analyses resultsSolid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirementsIn-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data typesPerforms 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 initiativesParticipate 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 experienceMinimum 5+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferredProgramming experience in SAS a must. Experience working with other languages (R) in validated environments strongly preferredIn-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 requirementsInterest 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

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