Lead Biostatistician

Role overview

A senior biostatistics position supporting clinical evidence generation and medical affairs initiatives within a medical device organization. The role combines hands-on statistical leadership with cross-functional collaboration and is structured as a remote-first opportunity, with onsite presence requested on an as-needed basis. It is classified at the professional career level and sits within the Clinical & Medical Affairs function.

Responsibilities

- Lead the design, execution, and interpretation of biostatistical analyses that support clinical and post-market evidence initiatives - Provide statistical input on study design, sampling strategy, and methodology in partnership with clinical and regulatory colleagues - Author or review statistical analysis plans and contribute meaningfully to clinical study reports and submission documentation - Mentor and review the work of other statisticians or quantitative contributors across multiple projects - Ensure statistical rigor, reproducibility, and alignment with applicable clinical and regulatory standards - Translate analytical findings into clear narratives for non-statistical audiences across medical affairs and clinical teams

Requirements

- Advanced degree in biostatistics, statistics, or a closely related quantitative discipline - Substantial professional experience applying biostatistics within a clinical, medical device, or similarly regulated research environment - Deep familiarity with clinical study design, data analysis workflows, and reporting practices - Proficiency with statistical programming tools and the manipulation of clinical or research datasets - Demonstrated leadership of statistical workstreams or cross-functional clinical projects - Strong written and verbal communication skills for both technical and non-technical stakeholders

Benefits and work setup

- Remote-first working arrangement, with onsite visits in the Sunnyvale, CA area scheduled when requested by leadership - Day-shift schedule, full-time employee status - Posted salary range of approximately $162,700 to $260,100 USD, varying by geographic region - Role aligned with a Clinical & Medical Affairs career track at the Professional 5 level