Biostatistics Consultant (US Based candidates only)

OverviewBiostatistics Consultant (US Based candidates only). Join to apply for the Biostatistics Consultant (US Based candidates only) role at St Andrews Church School.Role detailsTunnell Government Services, Inc. provides scientific, medical and technical expertise and human capital and organizational development professionals. This is a Full Time Position: Biostatistics Consultant in support of the Office of Product Evaluation (OPEQ), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA).ResponsibilitiesProvide expert consultant service in biostatistics consistent with applicable consensus standards such as FDA Guidance documents and webinars related to statistical data analysis.Adhere to applicable academic and professional consensus standards relevant to methodologies of data analysis used for clinical trials, biostatistics, real-world evidence, and regulatory domains.Support regulatory submittals and respond to questions related to access and use of clinical evidence; work with senior federal team members to achieve objectives.Research and perform analyses involving statistical aspects of regulatory submissions in alignment with statutory and agency guidelines (e.g., IDE under 21 CFR 812; Protection of Human Subjects under 21 CFR 50; IRBs under 21 CFR 56). Contribute to team decision-making regarding regulatory submissions.Carry out analyses as part of statistical evaluations of Investigational Device Exemptions and clinical trial data, including the assessment of safety and effectiveness, validity of pre-clinical data, and adequacy of trial design and data management.Participate in on-site and remote meetings to discuss regulatory submissions; work in a collaborative team environment and also perform independent research.Minimum Candidate RequirementsAdvanced degree in life sciences or related to statistics, computer science, or data scienceAt least 10 years of experience in relevant positions (or advanced regulatory/biomedical expertise may suffice in lieu of years of experience)Experience in statistical evaluation within life sciencesProgramming skills in SAS and RAbility to work collaboratively in a teamStrong communication skillsTunnell strives to hire and retain qualified talent and states that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Certain client contracts may require onsite work; employees/contractors are expected to comply with client requirements, including safety and health protocols.Job classificationsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Consulting, Information Technology, and SalesIndustries: Religious Institutions #J-18808-Ljbffr

Created: 2025-09-18