Part-Time Contract Statistical Programmer

Keros Therapeutics

Keros Therapeutics seeks a part-time contract statistical programmer to provide programming and analytical expertise for clinical development programs. The role involves designing SAS libraries, creating analysis specifications, overseeing CRO teams, and supporting regulatory submissions in a hybrid arrangement.

Responsibilities

Design and establish SAS program libraries for clinical trial reporting and statistical analyses
Develop specifications and SAS programs for data listings, patient profiles, and regulatory submissions
Support clinical data management documents including CRFs, data management plans, and CDISC specifications
Oversee CRO programming team activities to ensure quality and timely deliverables
Lead SDTM/ADaM dataset programming and author data specifications for regulatory filings

Requirements

Graduate degree in biostatistics, statistics, computer science, or related field
8+ years statistical programming experience in pharmaceutical or CRO industry
3+ years managing technical professionals in regulated environments
Strong SAS programming skills for clinical trials and macro development
Expert knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
Recent BLA/NDA or regulatory filing experience
Global clinical trial and CRO management experience

Apply

Vacancy posted 11 days ago

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