Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer, you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
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. This role can be performed as fully remote.
Responsibilities
How you will contribute:
* Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), 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 a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
* Being adaptable and flexible when priorities change.
Qualifications
To be successful in this position you will have:
* Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.
* At least 8 years of SAS programming experience 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.
* 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 immunology, respiratory or oncology 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.
Job Info
* Job Identification 310
* Job Category Statistical Programming - FSP
* Posting Date 12/20/2024, 04:30 PM
* Job Schedule Full time
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