Senior Statistical Programmer FSP

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

• 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

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field
• At least 8 years of SAS programming experience 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
• 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