• 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

• 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.

• 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.

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

5. Professionalism:  Be a leader and someone your customers and colleagues can count on by taking ownership and accountability for your work. Demonstrate a solution-oriented mindset and bias for action. Show empathy, dignity, and respect for each other. Be "high minded", maintain a calm demeanor when dealing with ambiguity or adversity and stay out of the fray (i.e., avoid drama).
5. Quality:  Do things right and do the right thing. Pursue excellence in your work by delivering quality services and products that provide high value and return on investment (ROI).
5. Teamwork:  Work with each other, the customer, and DRT. Demonstrate flexibility, a positive attitude and willingness to work collaboratively to help others and share information.
5. Customer Mission Focused: Commit to customer success and strive to exceed expectations by understanding the mission, executing the customer's vision, and solving challenges to drive results and achieve mission goals. Build meaningful customer relationships by asking thoughtful questions, listening, and operating transparently.
5. Growth Mindedness:  Commit to company, team, and personal growth. Embrace an entrepreneurial spirit by actively seeking opportunities to support new customer projects and/or solve problems. Actively work to improve your skills, learn to be comfortable with ambiguity, and be resourceful and willing to figure things out and add value.

DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and qualified applicants for employment without regard to race, color, creed, religion, national origin, gender, sexual orientation, age, gender identity, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local laws.

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 HR@drtstrategies.com, or by dialing 571-482-2517.