Job Description

Responsibilities:

As a Senior Statistical Programmer, you will leverage your advanced SAS. programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials.
Performing data manipulation, analysis and reporting of clinical trial data, 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.
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.
Performing lead duties when called upon.
Serving as team player, with a 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.
7 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or 6 years of related experience with a master's degree.
Strong SAS data manipulation, analysis and reporting skills.
Good working knowledge of R and have applied it in clinical trial analysis.
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.
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.

Job Tags

Flexible hours,

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