Remote Clinical Data Scientist

Summary

Join DRT Strategies as a Clinical Data Scientist to support the Office of New Drugs within FDA's Center for Drug Evaluation and Research. This role will involve reviewing safety data sufficiency and integrity, conducting safety data analyses, and generating high-quality scientific reports.

Requirements

• Minimum of 3 years professional experience
• Technical proficiency in programming languages- R (mandatory)
• R programming – ability to troubleshoot errors in R
• Experience with CDISC format 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
• 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

Responsibilities

• Prepare, oversee, and maintain project schedules
• Develop safety data review plans (SDRPs) with clinical reviewers in advance of initial scoping meetings
• Execute SDRPs in support of marketing application review process
• Provide written reports regarding assessment of safety data sufficiency, integrity, and quality to clinical review teams
• Perform comprehensive safety data analyses and provide written reports containing standardized safety tables and figures to clinical review teams
• Conduct in-depth safety analyses for specific safety signals as requested by clinical review teams
• Verify safety data submitted by the applicant in the proposed drug label, clinical study report, and integrated summary of safety
• 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

Preferred Qualifications

• Proficiency to manipulate data using R programming
• Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc
• Experience on SAS programming
• Understands general concept of clinical trial design and drug development (e.g., adequate and well-controlled studies)
• Familiarity with FDA regulatory process
• Working experience at FDA
• Experience in clinical trials, especially statistical hypothesis testing methods
• Managerial experience- leading and mentoring a team

Benefits

Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetics, disability, or protected veteran status