Clinical Data Scientist, FDA

DRT Strategies, Inc.•Silver Spring, MD

9d•$100,000 - $130,000

About The Position

The Clinical Analyst contractor position provides scientific and clinical analytical support to the FDA Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) multidisciplinary review teams. The role supports evaluation of drug applications through clinical safety data review, labeling assessment, safety analyses, and preparation of scientific reports. It requires advanced knowledge of health and data sciences and the ability to apply scientific expertise to regulatory risk determinations. The position works with FDA stakeholders, especially clinical reviewers (Medical Officers) and statistical reviewers. Duties include assessing the sufficiency and integrity of safety data, analyzing and verifying applicant-submitted data, and producing scientific reports and summaries. This is a support role: regulatory decisions, final recommendations, and official communications with applicants remain the responsibility of qualified FDA federal employees. Contractor work products are subject to FDA review and approval.

Requirements

Minimum of 3 years of professional experience.
Proficiency in R is mandatory, including demonstrated use for data manipulation, analysis, and visualization in a clinical or regulatory research context.
Ability to troubleshoot errors in R.
Experience with CDISC data standards, including SDTM and ADaM, and safety dataset structures such as adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt.
Understanding of analytical methods such as longitudinal analysis, time-to-event analysis, and causal or correlation analyses for safety analyses and tables and figures.
Understanding of 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 adverse event evaluation, safety signal detection, and preparation of standardized safety tables and figures.
Strong analytical and statistical skills for assessing safety data.
Excellent organizational, time-management, verbal, and written communication skills.
Ability to independently manage varied projects amid frequent interruptions and shifting priorities.
Ability to organize a continuous flow of work, meet deadlines, and work independently within a multidisciplinary team.
Computer skills with Microsoft Office Suite, particularly PowerPoint, Word, and Excel, and Adobe Acrobat.
PharmD or PhD in a STEM discipline such as bioinformatics, public health, pharmacology, toxicology, biology, biomedical engineering, biostatistics, epidemiology, health informatics, or pharmaceutical science.
Ability to obtain and maintain a U.S. government Public Trust clearance.
Must be a U.S. citizen or lawful permanent resident (green card holder) to meet contract requirements.

Nice To Haves

Proficiency in manipulating data using R programming.
Experience with or knowledge of analytical software such as JReview, JMP, or JMP Clinical.
Experience in SAS programming.
Ability to apply scientific research principles, study design concepts, and methods to evaluate clinical drug development programs.
Experience applying clinical safety data analytical skills, including synthesizing clinical and scientific evidence to inform risk assessments.
Experience in clinical trials, especially statistical hypothesis-testing methods, and understanding of clinical trial design and drug development, including adequate and well-controlled studies.
Statistical background, including experience with biostatistical methods used in clinical trial design, analysis, and interpretation, such as survival analysis, mixed-effects models, and hypothesis testing.
Machine learning and AI background, including familiarity with predictive modeling techniques such as classification, regression, random forests, or neural networks and their potential use in drug safety evaluation and regulatory science.
Epidemiological background, including 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 issues.
Familiarity with the FDA regulatory process and/or work experience at FDA.

Responsibilities

Analyze and evaluate applicant-submitted data and prepare analytical summaries on the adequacy of safety data.
Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration.
Incorporate clinical safety review summaries into integrated multidisciplinary assessments and prepare, oversee, and maintain project schedules.
Assist in reviewing proposed drug labeling to assess whether safety claims are truthful and adequately supported.
Provide draft safety data analyses of labeling accuracy and completeness for FDA staff review.
Draft scientifically sufficient reports that 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 teams.
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.
Support clinical review teams preparing for meetings with drug company representatives, advisory committees, and external scientific bodies.
Lead meetings with clinical and statistical reviewers to present data-quality assessment results 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 for appropriate controlled terminology and safety dataset structure.
Interact with government and contractor teams to manage and monitor project progress, risks, issues, and action items.
Manage, organize, and update SharePoint sites.
Provide overall project support and perform other DRT tasks as assigned or requested by the Portfolio Manager and Account Lead.