Biostatistician

Tunnell Government Services • Bethesda, MD

11h

About The Position

Tunnell Government Services, Inc. is seeking a Biostatistics Consultant to support the Office of Product Evaluation (OPEQ), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). The contractor will provide expert biostatistics consulting consistent with applicable FDA guidance, webinars, and academic and professional consensus standards for statistical analysis, clinical trials, biostatistics, and real-world evidence.

Under the direction of federal personnel, the candidate will provide scientific, technical, and regulatory support for assessment of regulatory submissions and questions related to access to and use of clinical evidence. The work involves research and analyses of statistical aspects of submissions, evaluating whether statistical approaches are fit for purpose and adequately documented in accordance with applicable statutory and agency-specific guidance. The candidate's work will contribute to team-level decisions about regulatory submission status, in collaboration with more senior federal team members.

Analyses may address data used to establish device safety and effectiveness, including statistical evidence of benefit or reliability; validity of pre-clinical data; and adequacy of clinical-trial experimental approaches, design, protocols, monitoring, conduct, data management, analysis, and interpretation. The role includes participation in onsite and remote meetings and a combination of collaborative team tasks and independent research.

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; advanced expertise in the regulatory and/or biomedical domain may suffice 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 biostatistics consulting consistent with applicable FDA guidance and relevant academic and professional consensus standards.
• Provide scientific, technical, and regulatory statistical support 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 approaches are fit for purpose and adequately documented under applicable requirements and standards.
• Contribute research and analyses to team-level decisions regarding the status of regulatory submissions.
• Analyze data used to establish the safety and effectiveness of proposed devices, including statistical analyses demonstrating device benefit or reliability.
• Assess the validity of pre-clinical data as part of determining device safety and effectiveness.
• Assess the adequacy of clinical-trial design and execution, including protocols, data monitoring and conduct, data management, analysis, and interpretation.
• Participate in onsite and remote meetings to discuss regulatory submissions.
• Carry out collaborative team tasks and independent research in coordination with more senior federal team members.

What This Job Offers

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