Job Description
Sponsor-dedicated:
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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.
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Position Overview:
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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.
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Our values
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- We believe in applying scientific rigor to reveal the full promise inherent in data.
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- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
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- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
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- We prize innovation and seek intelligent solutions using leading-edge technology.
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How you will contribute:
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- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
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- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
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- Production and QC / validation programming
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- Generating complex ad-hoc reports utilizing raw data
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- Applying strong understanding/experience of Efficacy analysis
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- Creating and reviewing submission documents and eCRTs
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- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
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- Performing lead duties when called upon
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- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
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- Being adaptable and flexible when priorities change
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Qualifications
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Here at Cytel we want our employees to succeed, and we enable this success through consistent training, development and support. To be successful in this position you will have:
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- Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
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- At least 5 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or a master’s degree or above.
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- Study lead experience, preferably juggling multiple projects simultaneously preferred.
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- Strong SAS data manipulation, analysis and reporting skills.
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- Solid experience implementing the latest CDISC SDTM / ADaM standards.
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- Robust QC / validation skills.
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- Good ad-hoc reporting skills.
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- Proficiency in Efficacy analysis.
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- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
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- Submissions experience utilizing define.xml and other submission documents.
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- Experience supporting immunology, respiratory or oncology studies would be a plus.
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- Excellent analytical & troubleshooting skills.
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- Ability to provide quality output and deliverables, in adherence with challenging timelines.
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- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
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📌 Senior Statistical Programmer (India)
🏢 Cytel
📍 India