Cytel
Senior Clinical Programmer FSP
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Senior Clinical Programmer FSP
Senior Statistical Programmer – Pharmaceutical Industry
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.
About the Role
We believe in:
- Applying scientific rigor to reveal the full promise inherent in data.
- Nurturing intellectual curiosity and encouraging everyone to approach new challenges with enthusiasm and the desire for discovery.
- Collaboration and inviting a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- Innovation and seeking intelligent solutions using leading-edge technology.
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Responsibilities
How you will contribute:
- Performing data manipulation, analysis, and reporting of clinical trial data (Safety and Efficacy working on ISS/ISE), utilizing SAS programming.
- Generating and validating CDISC SDTM and ADaM datasets, as well as analysis files, and producing tables, listings, and figures (TLFs).
- Producing production QC/validation programming.
- Generating complex ad-hoc reports utilizing raw data.
- Applying a strong understanding/experience of efficacy analysis.
- Creating and reviewing submission documents and eCRTs.
- Communicating with and/or responding to internal cross-functional teams and the client for status updates, project specifications, issues, or inquiries.
- Performing lead duties when called upon.
- Serving as a team player, with a willingness to go the extra distance to achieve results, meet deadlines, and adapt when priorities change.
- Being adaptable and flexible to shifting priorities.
Qualifications
Here at Cytel, we want our employees to succeed through consistent training, development, and support. To excel in this position, you will have:
- A Bachelor’s degree in one of the following fields: Statistics, Computer Science, Mathematics, etc.
- At least 6 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry, with a bachelor’s degree or equivalent. or
- At least 4 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 CDISC’s SDTM/ADaM standards.
- Strong QC validation skills.
- Good ad-hoc reporting skills.
- Proficient in efficacy analysis.
- Familiarity with the drug development lifecycle and experience with manipulation, analysis, and reporting of clinical trials' data.
- Submissions experience, including define.xml and other submission documents.
- Experience supporting immunology, respiratory, or oncology studies (a plus).
- Excellent analytical & troubleshooting skills.
- Ability to deliver high-quality output and meet challenging timelines.
- Ability to work effectively in globally dispersed teams, including cross-cultural collaboration.
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