Principal Statistical Programmer - Katalyst Healthcares & Life Sciences
Irvine, CA 92602
About the Job
Responsibilities:
- Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming.
- Generating and validating SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs).
- Production and QC / validation programming.
- Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP.
- Demonstrate good understanding of the endpoints and data collection.
- Generating complex ad-hoc reports utilizing raw data.
- Applying strong understanding/experience of Efficacy analysis.
- Creating and reviewing submission documents and eCRTs.
- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status issues, or inquiries.
- Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, or related field.
- At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent.
- At least 6 years of related experience with a master's degree or above.
- Study lead experience, preferably juggling multiple projects simultaneously preferred.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- 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.
- Experience supporting Rare Diseases and Gastrointestinal studies would be a plus.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Source : Katalyst Healthcares & Life Sciences
