Senior Statistical Programmer

cGxPServe; Boston (MA); Remote; USD 100,000 - 140,000; Full time

Job summary

A leading company in the biotech industry is seeking a Senior Statistical Programmer with extensive SAS programming experience. This fully remote role involves supporting clinical trials by manipulating and analyzing trial data, generating reports, and ensuring adherence to CDISC standards. The ideal candidate will possess strong analytical skills and the ability to collaborate effectively in a global team environment.

Qualifications

• 8+ years of SAS programming in the Pharmaceutical & Biotech industry.
• Solid experience with CDISC SDTM / ADaM standards.
• Familiarity with drug development lifecycle and submission documents.

Responsibilities

• Lead or support Phase I-IV clinical trials with SAS programming.
• Perform data manipulation, analysis and reporting of clinical trial data.
• Generate and validate SDTM and ADaM datasets and TLFs.

Skills

SAS programming

Data manipulation

Efficacy analysis

Ad-hoc reporting

Analytical skills

Education

Bachelor's degree in Statistics, Computer Science, Mathematics

Master's degree or above

Job description

Responsibilities:

• 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.
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), 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 arts.
• 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.

Requirements:

• 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.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing the latest CDISC SDTM / ADaM standards.
• 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
• 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.