Текст заказа
Sponsor-dedicated
JOB DESCRIPTION
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.