Clinical Data Scientist, FDA (Mid)
$95,000–$125,000 year
On-siteSilver Spring, Maryland, United States
Job Summary
Analyze and evaluate submitted clinical safety data from applicants seeking new drug approvals, preparing analytical summaries on data adequacy and integrity. Review NDAs, BLAs, supplements, and amendments to draft analytical reports and recommendations for FDA reviewer consideration. Incorporate clinical safety data reviews into multi-disciplinary assessments and prepare clear summaries of clinical safety data tables, figures, and listings for FDA review teams. Draft scientifically sufficient reports of findings and correspondence identifying inadequacies in sponsor submissions. Lead meetings with clinical and statistical reviewers to present results from data quality assessments and standard safety analyses. Collaborate with CDER OND staff to optimize team processes, manage project schedules, and track action items. Maintain awareness of current clinical developments through literature review and support preparation of background materials for industry meetings. Requires a PhD or PharmD with R programming proficiency and experience with CDISC data standards.
Required Qualifications
- PhD or PharmD with minimum of 3 years professional experience
- Technical proficiency in programming languages- R (mandatory)
- 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
- This position requires the ability to obtain and maintain a U.S. government Public Trust clearance
- Candidates must be U.S. citizens or lawful permanent residents (green card holders)
Desired Qualifications
- 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
- PhD/PharmD or equivalent degrees are preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.