Principal Statistical Programmer
Principal Statistical Programmer
Posted on :
18-06-2025
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1 Vacancy
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Job Description
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 TLFs. 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.
- Bachelors 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 bachelors degree or equivalent. At least 6 years of related experience with a masters 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 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.
Employment Type
Full Time
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