Medical Device Biostatistician

Tunnell Government Services • Bethesda, MD

1d

About The Position

Tunnell Government Services is hiring a full-time Medical Device Biostatistics Consultant to support the Office of Product Evaluation (OPEQ) in the FDA’s Center for Devices and Radiological Health (CDRH). The consultant will provide expert biostatistical advice and services consistent with applicable FDA guidance and relevant academic and professional consensus standards for clinical trials, biostatistics, real-world evidence, and regulatory data analysis.

Under the direction of federal personnel, the consultant will provide scientific, technical, and regulatory support for assessing regulatory submissions and responding to questions about access to and use of clinical evidence. Work will be done with more senior federal team members, combining independent research and analysis with collaborative team tasks. The consultant’s research and analyses will help inform team-level decisions regarding regulatory submissions.

The role includes assessing statistical aspects of regulatory submissions and evaluating whether proposed statistical approaches are fit for purpose and adequately documented, with reference to applicable statutory and agency-specific requirements. Analyses may address data supporting device safety and effectiveness, including demonstrated benefit or reliability; the validity of preclinical data; and the adequacy of clinical-trial design and execution, including protocols, monitoring and conduct, data management, analysis, and interpretation. The consultant will also participate in onsite and remote meetings about regulatory submissions.

Requirements

• Advanced degree in life sciences or another area relevant to statistics, computer science, or data science.
• At least 10 years of experience in relevant positions, unless advanced expertise in the regulatory and/or biomedical domain is offered in lieu of years of experience.
• Experience conducting statistical evaluation in the life sciences.
• Programming skills in SAS and R.
• Ability to work collaboratively in a team environment.
• Strong communication skills.
• Must be a United States citizen or a full Green Card holder.

Responsibilities

• Provide expert biostatistical consulting consistent with applicable FDA guidance and relevant academic and professional consensus standards.
• Provide scientific, technical, and regulatory support in statistics for assessment of regulatory submissions and questions concerning access to and use of clinical evidence.
• Research and analyze statistical aspects of regulatory submissions, including whether statistical approaches are fit for purpose and adequately documented.
• Assess data used to establish the safety and effectiveness of proposed medical devices, including statistical analyses of device benefit and/or reliability.
• Assess the validity of preclinical data as part of determining device safety and effectiveness.
• Evaluate the adequacy of clinical-trial experimental approaches, including trial design and protocol development, monitoring and conduct, data management, data analysis, and interpretation of results.
• Collaborate with more senior federal team members; contribute research and analyses to team-level regulatory decision-making.
• Participate in onsite and remote meetings to discuss regulatory submissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior