Lead or support Phase I-IV clinical trial programming using SAS and CDISC standards to generate and validate SDTM/ADaM datasets, TLFs, and submission documents. Perform production and QC/validation programming, complex ad-hoc reports, and efficacy analyses while coordinating with cross-functional teams and serving as study lead when required.
Sponsor-dedicated:
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.
Our values
- We believe in applying scientific rigor to reveal the full promise inherent in data.
- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- We prize innovation and seek intelligent solutions using leading-edge technology.
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 team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
- Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
- At least 8 years of SAS programming 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 preferred.
- 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.
Cytel Cambridge, Massachusetts, USA Office
Cambridge, MA, United States
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