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Senior Statistical Programmer FSP

Senior Statistical Programmer FSP

CytelAlappuzha, Kerala, India
12 days ago
Job description

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.

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 team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change
  • Qualifications

    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 :

  • 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.
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    Statistical Programmer • Alappuzha, Kerala, India

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