Senior Statistical Programmer FSP

About the Role

As a Senior Statistical Programmer, you will be fully embedded within one of our pharmaceutical clients, leveraging 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 fully remote and offers autonomy and ownership within a global pharmaceutical company driving the next generation of patient treatment.

Our Values

• Applying scientific rigor to reveal the full promise inherent in data.
• Nurturing intellectual curiosity and encouraging enthusiasm for new challenges and discovery.
• Valuing collaboration and diversity of perspectives to create a wealth of possibilities.
• Prizing innovation and seeking intelligent solutions using leading-edge technology.

Responsibilities

• Perform data manipulation, analysis, and reporting of clinical trial data (safety and efficacy, ISS/ISE) using SAS programming.
• Generate and validate SDTM and ADaM datasets, analysis files, tables, listings, and figures (TLFs).
• Develop and QC/validate programming for clinical trial outputs.
• Create complex ad-hoc reports utilizing raw data.
• Apply strong understanding and experience in efficacy analysis.
• Develop and review submission documents and eCRTs.
• Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, or inquiries.
• Perform lead duties, including managing multiple projects simultaneously when required.
• Serve as a team player, demonstrating adaptability and flexibility when priorities change.

Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.
• At least 8 years of SAS programming experience with clinical trial data in the pharmaceutical & biotech industry (or at least 6 years with a master’s degree or above).
• Study lead experience, preferably juggling multiple projects simultaneously.
• Strong SAS data manipulation, analysis, and reporting skills.
• Solid experience implementing the latest CDISC SDTM/ADaM standards.
• Strong QC/validation skills and proficiency in efficacy analysis.
• Familiarity with the drug development life cycle and clinical trial data manipulation, analysis, and reporting.
• Submissions experience utilizing define.xml and other submission documents.
• Experience supporting immunology, respiratory, or oncology studies (a plus).
• Excellent analytical and troubleshooting skills.
• Ability to deliver high-quality output under challenging timelines.
• Ability to work effectively in a globally dispersed, cross-cultural team environment.