DRT Strategies, Inc.
FDA IPS3 - Principal Systems Architect for FDA CDS Project
Silver Spring, MD - Full Time
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:
The U.S Food and Drug Administration Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. To accomplish its mission, CDER OND follows a process for drug reviews called the CDER 21st Century Review Process, which includes specific reviewer activities and timelines for completion of various review milestones. On this project, CDER OND aims to achieve analytical and safety planning and reporting that will enable reviewers to execute OND’s mission. Reviewers will support OND’s Integrated Review for New Drug Marketing Applications program by conducting comprehensive safety data quality assessments and safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers.
Job Summary:
DRT is looking for a Principal Systems Architect (Data Scientist) with a PhD or PharmD degree and strong R programming skills for data analysis. The ideal candidate will possess a deep understanding of clinical data structures, trial design, and analytical methods, including CDISC format. Key responsibilities involve developing and executing safety data review plans (SDRPs), performing comprehensive safety analyses, and providing detailed written reports and presentations to clinical review teams. This position requires an individual who can proactively identify and solve problems related to workflows and data quality, and who can serve as a subject matter expert in meetings with stakeholders. The role demands excellent communication skills, a team-oriented attitude, and the ability to verify safety data for proposed drug labels and marketing applications.
Responsibilities:
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 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:
The U.S Food and Drug Administration Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. To accomplish its mission, CDER OND follows a process for drug reviews called the CDER 21st Century Review Process, which includes specific reviewer activities and timelines for completion of various review milestones. On this project, CDER OND aims to achieve analytical and safety planning and reporting that will enable reviewers to execute OND’s mission. Reviewers will support OND’s Integrated Review for New Drug Marketing Applications program by conducting comprehensive safety data quality assessments and safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers.
Job Summary:
DRT is looking for a Principal Systems Architect (Data Scientist) with a PhD or PharmD degree and strong R programming skills for data analysis. The ideal candidate will possess a deep understanding of clinical data structures, trial design, and analytical methods, including CDISC format. Key responsibilities involve developing and executing safety data review plans (SDRPs), performing comprehensive safety analyses, and providing detailed written reports and presentations to clinical review teams. This position requires an individual who can proactively identify and solve problems related to workflows and data quality, and who can serve as a subject matter expert in meetings with stakeholders. The role demands excellent communication skills, a team-oriented attitude, and the ability to verify safety data for proposed drug labels and marketing applications.
Responsibilities:
- A successful candidate is required to fulfill the below to be considered:
- Have a PhD (in pharmaceutical sciences, pharmacology, data science, informatics, public health, or epidemiology related fields) or PharmD degree.
- Possess strong R programming skills of data analysis and a deep understanding of clinical data structure, clinical trial design, and safety data analytical methods.
- Have demonstrated experience with CDISC format and safety dataset structure (adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt).
- Understand data analytical methods (time-to-event analyses, causal/correlation analyses, longitudinal analyses, etc.) for conducting safety data analyses (tables and figures).
- Understand safety review elements (including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, vital signs).
- Possess excellent written and oral communication skills.
- Demonstrate a forward-thinking, team-oriented attitude.
- Prepare, maintain, and perform quality control/oversight of project schedules.
- Evaluate analytically and systematically problems of workflows, organization, and planning and develops appropriate corrective action.
- Develop safety data review plans (SDRPs) with clinical reviews before initial scoping meetings.
- Execute SDRPs in support or marketing application review process.
- Develop and submit written reports covering assessment of safety data sufficiency, integrity, and quality to clinical review teams.
- Perform comprehensive safety data analyses; 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 in the proposed drug label, clinical study report, and integrated summary of safety.
- Lead meetings with clinical and statistical reviewers; present results from data quality assessments and standard safety data analyses.
- Meet with CDER OND staff as needed.
- Work with stakeholders to review background packages and mock safety data sets to assess appropriateness of controlled terminology and safety dataset structure.
- 8-10 years of clinical safety or data scientist experience
- N/A
- Minimum of PhD in related field or PharmD.
- Salary commensurate with experience.
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 HR@drtstrategies.com, or by dialing 571-482-2517.
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