Description:

About the job

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:

- Bachelors 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 bachelors degree or equivalent.

- At least 6 years of related experience with a masters 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