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~Clinical Data Scientist (Evergreen)
$92k-130k (estimate)
Full Time | IT Outsourcing & Consulting
2 Months Ago
DRT Strategies is Hiring a Remote ~Clinical Data Scientist (Evergreen)
This job is an evergreen position posted for networking purposes. While we do not have any current open positions, we are always looking to increase our network of top talent for future work. If you are interested in becoming part of DRT Strategies in the future, please apply.
OverviewDRT 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 your vision a reality.Project DescriptionThis 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 SummaryThe 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
OverviewDRT 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 your vision a reality.Project DescriptionThis 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 SummaryThe 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
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
IT Outsourcing & Consulting
SALARY
$92k-130k (estimate)
POST DATE
03/27/2024
EXPIRATION DATE
07/30/2024
WEBSITE
drtstrategies.com
HEADQUARTERS
ARLINGTON, VA
SIZE
200 - 500
FOUNDED
2004
TYPE
Private
CEO
SUSAN MALYN KIDD
REVENUE
$50M - $200M
INDUSTRY
IT Outsourcing & Consulting
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About DRT Strategies
DRT Strategies is a provider of expert management consulting and Information Technology solutions.
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The job skills required for ~Clinical Data Scientist (Evergreen) include Analysis, Collaboration, Written Communication, Leadership, Clinical Trial, Time Management, etc. Having related job skills and expertise will give you an advantage when applying to be a ~Clinical Data Scientist (Evergreen). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by ~Clinical Data Scientist (Evergreen). Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for ~Clinical Data Scientist (Evergreen) positions, which can be used as a reference in future career path planning. As a ~Clinical Data Scientist (Evergreen), it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary ~Clinical Data Scientist (Evergreen). You can explore the career advancement for a ~Clinical Data Scientist (Evergreen) below and select your interested title to get hiring information.
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