Senior Statistical Programmer FSP

Cytel; Richmond (VA); On-site; USD 110,000 - 170,000; Full time

Job summary

Cytel is seeking a Senior Statistical Programmer to support or lead SDTM/ADaM programming for one or more clinical trials. This role emphasizes SAS-based data manipulation, analysis and reporting, including ISS/ISE, with potential to work remotely and collaborate with a global client team.

In this position, you will generate and validate SDTM/ADaM datasets, create tables, listings and figures, contribute to submission documents, and provide QC/lead duties as needed while maintaining strict

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
• At least 8 years of SAS programming in pharma/biotech with a bachelor’s; at least 6 years with a master's or above.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing CDISC SDTM/ADaM standards.
• Experience generating SDTM/ADaM datasets and TLFs.
• Submissions experience with define.xml and submission documents.

Responsibilities

• Perform data manipulation, analysis and reporting of clinical trial data (safety/efficacy) using SAS.
• Generate/validate SDTM/ADaM datasets and TLFs.
• Production and QC/validation programming.
• Create complex ad-hoc reports from raw data.
• Lead duties when called upon and collaborate with cross-functional teams.
• Contribute to submission documents and eCRTs.

Skills

SAS programming

CDISC SDTM/ADaM

Data analysis

Ad-hoc reporting

Submission documents

QC/validation

Lead duties

Efficacy analysis

Cross-functional communication

Education

Bachelor's degree in Statistics/CS/Math

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.

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

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.

Cytel Inc. is an Equal Employment /Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.