Manager, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and supervise statistical programming outputs, including Analysis Data Sets (ADS) and Tables, Listings, and Figures (TLF), ensuring the integrity of data and adherence to regulatory standards such as ICH, GCP, and FDA 21 CFR Part 11.

• Potentially oversee a team of statistical programmers, fostering their technical and professional growth while also engaging directly in programming tasks.

• Serve as the primary programming lead for regulatory submissions, which may involve 510(k), Clinical Trial Applications (CTA/CDx), and Premarket Approvals (PMA).

• Sustain programming infrastructure, which includes the development, validation, and upkeep of R packages in a controlled setting.

• Create R Shiny dashboards that facilitate data review, study monitoring, and the exploration of analytical results.

• Advocate for best practices in the development and validation of statistical programming.

• Collaborate across various functions, including Biostatistics, Data Management, Clinical Science, and others.

⛳️ Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science, or a related discipline.

• Over 5 years of relevant experience.

• Minimum of 3 years of experience in Clinical Trial analysis.

• At least 3 years of experience in R programming, including the development of packages.

• Expertise in R programming, particularly in building and maintaining packages.

• Experience in generating analysis datasets and TLFs.

• Previous experience in Next Generation Sequencing (NGS), genetics, and/or oncology diagnostics is preferred.

• Experience in maintaining statistical computing environments is advantageous.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability insurance plans for eligible employees and their families.

• Complimentary testing for employees and their immediate family members.

• Fertility care assistance.

• Leave benefits for pregnancy and bonding with a new baby.

• 401(k) retirement plan options.

• Commuter benefits.

• Employee referral program.