Senior Principal Statistical Programmer - Clinical Lead

Katalyst CRO; Newark (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO in the United States is seeking a Senior Manager in Statistics to lead statistical activities across clinical trials from protocol development to final study report and in-licensing activities.

The role requires a Ph.D. or MS in Statistics or Biostatistics, hands-on SAS expertise, and leadership to guide CRO statisticians and programmers while ensuring compliance with ICH, CDISC, and FDA guidelines.

Qualifications

• Ph.D. or MS in Statistics or Biostatistics is required.
• Experience in pharmaceutical/CRO settings is required.
• Strong knowledge of SAS and regulatory guidelines (ICH, CDISC, FDA) is essential.

Responsibilities

• Review protocols and design study elements including sample size calculations and analysis methods.
• Review CRFs, database design, and edit check specs.
• Provide statistical and validation support for analyses and datasets.
• Lead CRO statisticians and statistical programmers and supervise deliverables.
• Prepare SAP, TFL shells and specifications for variable derivation.
• Respond to health authority requests with appropriate statistical inputs.

Skills

Statistical leadership

Clinical trials design

SAS programming

Regulatory guidelines

Cross-functional collaboration

Education

Ph.D. in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

SAS

Job description

Katalyst CRO in the United States is seeking a Senior Manager in Statistics to lead statistical activities across clinical trials from protocol development to final study report and in-licensing activities.

The role requires a Ph.D. or MS in Statistics or Biostatistics, hands-on SAS expertise, and leadership to guide CRO statisticians and programmers while ensuring compliance with ICH, CDISC, and FDA guidelines.