Program, analyze, and report clinical trial safety and efficacy data using SAS, including generating and validating SDTM and ADaM datasets and tables, listings, and figures. Support or lead clinical studies, prepare submission documents, produce ad-hoc reports, and coordinate with client and cross-functional teams on specifications, status, and issues.
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 is fully remote. Experience with oncology is a plus.
Responsibilities
How you will contribute:
Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, 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
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 oncology or immunology 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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