Clinical Data Scientist, FDA (Sr.)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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. and )
• 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.

• 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.

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

• 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.
• No agencies third parties or Corp-to-Corp submissions.

• $00
• Salary commensurate with experience.

DRT Strategies Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race color religion sex (including pregnancy childbirth or related conditions transgender status and sexual orientation) national origin age genetic information disability protected veteran status or any other protected characteristic under federal state or local law.

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