Job Summary

Responsibilities

Acting as a lead programmer on several different projects while being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables
Be an expert solution provider, guide & mentor statistical programmers to develop and manage high performing teams
Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
Generating, validating, reviewing 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
Generating, validating, reviewing submission packages
Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
Willingness to go the extra distance to get results, meet deadlines, etc.
Being adaptable and flexible when priorities change

Requirements

Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
At least 10 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 8 years of related experience with a master’s degree or above.
Consistent experience as a lead statistical programmer on several concurrent projects
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.
Experience supporting GI, Rare diseases, Hematology studies is 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.