Clinical Data Scientist, FDA (Sr.)

drtstrategies; Silver Spring (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

DRT Strategies seeks a Clinical Data Scientist contractor to support FDA CDER OND with safety data analyses, safety reporting, and regulatory documentation. You will review submissions, generate analytical reports, and collaborate with multi-disciplinary teams across offices.

Required expertise includes R programming, CDISC SDTM/ADaM, and strong communication skills to deliver high-quality scientific outputs within regulatory timelines.

Qualifications

• Minimum 3 years’ professional experience.
• Proficiency in R for data manipulation, analysis and visualization in a clinical or regulatory context.
• Experience with CDISC SDTM/ADaM and safety dataset structures (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, adeg.xpt).
• Knowledge of safety data analysis methods and regulatory review processes.

Responsibilities

• Analyze and evaluate data from applicants seeking permission to market new drugs and prepare analytical summaries on safety data adequacy.
• Review NDAs, BLAs, supplements and amendments; draft analytical reports and recommendations for FDA reviewers.
• Prepare safety data analyses for labeling review and ensure accuracy of safety tables and listings.
• Draft scientific reports of findings and prepare correspondence for sponsor submissions and FDA review teams.

Skills

R programming

Data analysis

Regulatory data review

Statistical methods

Safety data analysis

Executive communication

Education

PharmD or PhD in STEM disciplines

Tools

JReview

SAS

JMP Clinical

Job description

Overview

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 Data Scientist 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

• 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., longitudinal analysis, time-to-event analyses, and causal/correlation analyses) for conducting safety data analyses (tables and figures)
• Understands safety review elements including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs. Working knowledge of safety analysis methods, including the evaluation of adverse event data, safety signal detection, and the preparation of standardized safety tables and figures.
• Strong analytical and statistical skills to assess safety data.
• Excellent organizational, time management, verbal and written communication skills.
• Ability to independently manage a variety of projects with frequent interruptions and shifting priorities.
• Ability to organize a continuous flow of work in a timely manner and meet mandatory deadlines.
• Computer skills: MS Office Suite (particularly PowerPoint, Word, Excel), Adobe Acrobat.
• Ability to work independently within a multidisciplinary team.

Preferred Experience

• Proficiency in manipulating data using R programming.
• Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc.
• Experience in SAS programming.
• Ability to apply knowledge of scientific research principles, study design concepts, and methods sufficient to evaluate clinical drug development programs.
• Experience in applying clinical safety data analytical skills, including the ability to synthesize clinical and scientific evidence to inform risk assessments.
• Experience in clinical trials, especially statistical hypothesis testing methods. Understands general concept of clinical trial design and drug development (e.g., adequate and well-controlled studies).
• Statistical background, including experience with biostatistical methods commonly applied in clinical trial design, analysis, and interpretation (e.g., survival analysis, mixed-effects models, hypothesis testing).
• Machine learning and AI background, including familiarity with predictive modeling techniques (e.g., classification models, regression models, random forest, or neural networks) and their potential applications in drug safety evaluation and regulatory science.
• Epidemiological background, including experience with observational study design, real-world evidence, pharmacoepidemiology, or population-level safety surveillance methods.
• Ability to work with little direct supervision on loosely defined tasks and coordinate work across multiple projects.
• Experience identifying, articulating, and resolving complex, unique, and previously unresolved.
• Familiarity with FDA regulatory process and/or working experience at FDA.

Education & Training

• PharmD or PhD in the STEM disciplines: bioinformatics, Public Health, Pharmacology, Toxicology, Biology, Biomedical Engineer, biology, biostatistics, epidemiology, health informatics, or pharmaceutical science.

Work Authorization, Clearance Requirement, & Additional Information

• This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.