Clinical Data Scientist, FDA (Mid)

About the role

DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries. The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together. We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality. Project Description: The Clinical Analyst contractor position provides scientific and clinical analytical support to CDER Office of New Drugs (OND) multi-disciplinary review teams. The individual will assist in the evaluation of drug applications, review clinical safety data, labeling assessment, and preparation of scientific reports. The work requires advanced knowledge in health and data sciences and the ability to apply scientific expertise to support risk determinations in the context of regulatory review. Note: This is a support role. All regulatory decisions, final recommendations, and official communications with applicants remain the exclusive responsibility of qualified FDA federal employees. The contractor's work products are subject to review and approval by FDA staff. Job Summary: The Clinical Analyst position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers. This role will be responsible for reviewing safety data sufficiency and integrity, conducting safety data analyses, verifying safety data submitted by the applicant, and generating high-quality scientific reports.

Responsibilities

• Clinical Data Analysis and Review
• Analyze and evaluate submitted data from applicants seeking permission to market new drugs for general use and prepare analytical summaries on the adequacy of safety data provided.
• Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration.
• Incorporate summaries from clinical safety data reviews as part of integrated multi- disciplinary assessments. Prepare, oversee, and maintain project schedules.
• Labeling Review Support
• Assist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported.
• Provide draft safety data analysis on labeling accuracy and completeness for review by FDA staff.
• Scientific Correspondence and Reporting
• Draft scientifically sufficient reports of findings that clearly communicate clinical safety analyses and conclusions.
• Prepare draft correspondence identifying facts and information inadequately presented in sponsor submissions, for FDA reviewer finalization and issuance.
• Prepare clear summaries of clinical safety data tables, figures and listings for FDA review team use.
• Literature Review and Knowledge Management
• Review scientific literature and maintain awareness of current clinical developments and evolving findings in relevant therapeutic areas.
• Support preparation of background materials for seminars, conferences, and industry meetings.
• Stakeholder Support
• Support clinical review teams in preparing for meetings with drug company representatives, advisory committees, and external scientific bodies.
• Other Tasks
• Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses.
• Collaborate with CDER OND staff to optimize team processes and deliverables.
• Work with FDA stakeholders to review background packages and mock safety datasets to assess appropriateness of controlled terminology and safety dataset structure.
• Interact with government and contractor teams to help manage and monitor project progress, risk, issues, and track action items.
• Manage, organize, and update SharePoint sites.
• Assist in overall project support, as needed.
• Support any other DRT tasks as assigned/requested by Portfolio Manager and Account Lead.
• Required Experience:
• PhD or PharmD with minimum of 3 years professional experience.
• Technical proficiency in programming languages- R (mandatory) with demonstrated experience using R for data manipulation, analysis, and visualization in a clinical or regulatory research context.
• R programming - ability to troubleshoot errors in R.
• Experience with CDISC data standards (including SDTM and ADaM) and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt)
• Understands data analytical methods (e.g

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