Senior Statistical Programmer FSP

Cytel

Remote

Position Overview:

As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (ADaM) and TLFs to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.

Responsibilities

How you will contribute:

Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming (and potentially R);
Generating and validating 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;
Experience using R is a plus. Willingness to learn and use R in the future is expected.