
Clinical Data Scientist
1 day ago
Sponsor-dedicated: As a leading figure in our client's innovation, you'll be at the heart of driving the next generation of patient treatment. This is an exciting time to be part of this new program.
Position Overview:
This role leverages advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This position can be performed as fully remote.
We believe in applying scientific rigor to reveal the full promise inherent in data.
- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- We prize innovation and seek intelligent solutions using leading-edge technology.
Key Responsibilities:
The ideal candidate will have the following skills and qualifications:
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
- Production and QC / validation programming
- Generating complex ad-hoc reports utilizing raw data
- Applying strong understanding/experience of Efficacy analysis
- Creating and reviewing submission documents and eCRTs
- Communicating with internal cross-functional teams and clients for project specifications, status, issues or inquiries
- Performing lead duties when called upon
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
Candidate Profile:
Here are some requirements for success in this position:
- Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
- At least 7 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 5 years of related experience with a master's degree or above.
- Study lead experience, preferably juggling multiple projects simultaneously preferred.
- Strong SAS data manipulation, analysis and reporting skills.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Strong QC / validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
- Submissions experience utilizing define.xml and other submission documents.
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