Senior Statistical Programmer, Clinical Trials (SAS/CDISC)

Keros Therapeutics; Lexington (MA); On-site; USD 157,000 - 183,000; Full time

Job summary

Keros Therapeutics is seeking an experienced Senior Statistical Programmer to provide cross-functional statistical programming leadership within its Biometrics team. You will oversee SAS programming activities across clinical development programs, draft custom reports, and ensure SDTM/ADaM compliance for regulatory submissions.

The role reports to the head of Biometrics and involves collaboration with Data Management, Biostatistics, and Clinical Development Operations to drive data quality and

Qualifications

• Graduate degree in Biostatistics/Statistics, Computer Science or a related field with 8+ years of statistical programming experience in the pharmaceutical / CRO industry.
• 3+ years of overseeing technical professionals in a regulated environment.
• Experience building in‑house statistical computing environment, SOPs and processes.
• Strong hands‑on SAS programming skills on both clinical trial reporting and system macro development. General knowledge of R is a plus.
• Expert knowledge with CDISC standards for SDTM and ADaM and statistical programming requirements for regulatory submissions.

Responsibilities

• Design/Establish SAS program library for clinical trial reporting, data review tools, and statistical analyses.
• Draft and finalize custom report programming specifications for data listings, patient profiles, data displays and metrics reporting.
• Develop SAS programs and macros and provide hands-on SAS programming support.
• Review clinical data management study documents and SDTM/ADaM related artifacts.
• Lead programming activities in regulatory filings and oversee CRO programming.
• Oversee SDTM/ADaM datasets, TFLs, and reviewer guidance documents.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Team leadership

Cross-functional collaboration

Education

Biostatistics/Statistics or CS degree

Tools

SAS

R

Pinnacle 21

Job description

Keros Therapeutics is seeking an experienced Senior Statistical Programmer to provide cross-functional statistical programming leadership within its Biometrics team. You will oversee SAS programming activities across clinical development programs, draft custom reports, and ensure SDTM/ADaM compliance for regulatory submissions.

The role reports to the head of Biometrics and involves collaboration with Data Management, Biostatistics, and Clinical Development Operations to drive data quality and