Job Description

OVERVIEW

DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and the financial services industries.

The three letters of our name, DRT, stand for Driving Resolutions Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing IT 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 your vision a reality.

PROJECT SUMMARY 

This project will support the Office of New Drugs within FDA’s Center for Drug Evaluation and Research (CDER). Specifically, this project will support OND’s Integrated Review for Drug Marketing Applications program by providing comprehensive safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers.

POSITION 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

• Develop safety data analysis plans (SDAPs) with clinical reviewers in advance of initial scoping meetings. Execute SDAPs 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
• Manage, organize, and update SharePoint sites
• Assist in overall project support, as needed

REQUIRED EXPERIENCE 

• 2+ years of relevant experience in STEM disciplines: bioinformatics, Public Health, Pharmacology, Toxicology, Biology, Biomedical Engineer, biology, biostatistics, computer science, epidemiology, health informatics, or pharmaceutical science
• Technical proficiency in R 
• 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

• Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc.
• Working experience at FDA
• Familiarity with FDA regulatory process
• Experience in clinical trials, especially statistical hypothesis testing methods
• Managerial experience - leading and mentoring a team

EDUCATION AND TRAINING

• PharmD or PhD

Presently, due to the COVID-19 pandemic, DRT employees are teleworking from home and leveraging video conferencing along with other virtual productivity tools. During normal circumstances, the requirement of this position is to be onsite, however, DRT has not yet determined when employees will be required to return to their workspaces. Please be aware that at the time a date is determined, the requirement of this position will be to report to the worksite.

DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide 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. In addition to federal law requirements, DRT complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.

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