Senior Statistical Programming Lead (Remote)

Definium Therapeutics; Philadelphia (Philadelphia County); Remote; USD 155,000 - 195,000; Full time

Benefits offered by this job

Health benefits

401(k) with match

Flexible time off

Parental leave

Job summary

Definium Therapeutics, a late-stage biopharmaceutical company, seeks an Associate Director, Statistical Programming to lead programming for multiple clinical trials from development through regulatory submission. This remote role partners with statisticians, data management, and vendors to ensure high-quality, timely deliverables.

The successful candidate has a master's in biostatistics or related field and at least 12 years in clinical trial programming, with proficiency in SAS, Define XML, and

Qualifications

• Master's Degree in Biostatistics, Statistics, Computer Science or related field.
• At least 12 years of experience in statistical programming for clinical trials.
• Proficient in SAS programming, including data steps and macros.
• Strong knowledge of Pinnacle 21 validation and Define XML packages.
• Experience collaborating with biostatisticians, data management and vendors.

Responsibilities

• Serve as study lead programmer for assigned clinical trials and collaborate with study statistician and data management.
• Review and ensure high quality Define packages (aCRF, SDTM/ADaM, Pinnacle 21, XML) for regulatory submissions.
• Perform independent validation of datasets and analytic outputs.
• Produce systematic data reports to support data review and cleaning.
• Contribute to Statistical Analysis Plans and tables/listings/figures.

Job description

Definium Therapeutics, a late-stage biopharmaceutical company, seeks an Associate Director, Statistical Programming to lead programming for multiple clinical trials from development through regulatory submission. This remote role partners with statisticians, data management, and vendors to ensure high-quality, timely deliverables.

The successful candidate has a master's in biostatistics or related field and at least 12 years in clinical trial programming, with proficiency in SAS, Define XML, and