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 adhoc reports utilizing raw data.
Requirements:
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.
Strong SAS data manipulation analysis and reporting skills.
Solid experience implementing the latest CDISC SDTM / ADaM standards.
Strong QC / validation skills.
Proficiency in Efficacy analysis.
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 crosscultural partners.
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