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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 financial services industries.

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

Project Description:

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.

Job 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:

+ 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

Require Experience:

+ Minimum of 10 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.

Preferred Experience:

+ Advanced degree or certification

+ 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.

Education & Training:

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

Salary Range:

+ Salary commensurate with experience.

Company Benefits:

DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).

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.

Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing [email protected], or by dialing 571-482-2517.

For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).

Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at [email protected] if you believe you have received a fraudulent email.

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