Senior Clinical Data Analyst
Company: DRT Strategies, Inc.
Location: Silver Spring
Posted on: August 15, 2019
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 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 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.
This project will support the FDA's Center for Drug Evaluation and
Research (CDER), in particular the Office of New Drugs (OND).
Specifically, this project will support OND's user fee
documentations and reviews by providing technical support to Safety
Data Analysis Plan (SDAP).
The clinical data analyst 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 the reviewing of clinical data
sufficiency and integrity, verifying clinical safety data, and
conducting standardized clinical safety analyses. The clinical data
analyst will work closely with medical editors on the marketing
application review and provide ad-hoc support, as needed.
- Work with FDA stakeholders to review background packages and
mock safety datasets to assess appropriateness of controlled
terminology and safety dataset structure
- Develop SDAPs with clinical reviewers in advance of initial
scoping meetings. Execute SDAPs in support of marketing application
- Provide written reports regarding assessment of safety data
sufficiency, integrity, and quality to clinical review teams
- Conduct preliminary safety assessments and provide written
reports to clinical review teams
- Perform comprehensive safety data analyses and provide written
reports containing standardized safety tables and figures to
clinical review teams. Create additional safety tables and figures
based on requests of clinical review teams
- Manage, organize, and update SharePoint sites
- Assist in overall project support, as needed
- Masters (with 5+ years of relevant experience) or PhD (with 2+
years of relevant experience) in the STEM disciplines:
bioinformatics, biology, biostatistics, computer science,
epidemiology, or health informatics
- Technical proficiency in programming languages, Python and
- Strong analytical and statistical skills to assess safety
- Excellent organizational, time management, and communication
- Ability to independently manage a variety of projects with
frequent interruptions and shifting priorities to organize a
continuous flow of work in a timely manner and meet mandatory
- Computer skills: MS Office Suite (particularly PowerPoint,
Word, Excel), Adobe Acrobat
- Ability to work independently and within a multidisciplinary
- Advanced Degree or Certifications
- Experience and/or knowledge of analytical software including
JReview, JMP, JMP Clinical, etc.
- Familiarity with FDA regulatory process
- Experience in clinical trials, especially statistical
hypothesis testing methods
- Managerial experience - leading and mentoring a team.
Education and Training
- Masters Degree or PhD in STEM or relevant field required
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.
Keywords: DRT Strategies, Inc., Silver Spring , Senior Clinical Data Analyst, Healthcare , Silver Spring, Maryland
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