Senior Principal Statistical Programmer - Clinical Trials

Katalyst CRO; Paramus (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Katalyst CRO in Paramus, New Jersey, is seeking a Senior Manager in Statistics to lead statistical activities across clinical trials from protocol development through final study report. The role requires directing SAS-based analyses, coordinating with statisticians and programmers, and ensuring compliance with ICH, CDISC, and FDA guidelines.

Strong leadership and communication skills are essential to drive timelines and regulatory deliverables.

Qualifications

• Ph.D. or MS in Statistics or Biostatistics required.
• Industry experience in pharmaceutical/CRO environments preferred.
• Strong leadership and communication skills to manage statisticians and programmers.

Responsibilities

• Review protocol, understand study requirements, and design study elements including sample size calculation, analysis methods.
• Review CRF, database design, and edit check specs.
• Review study quality surveillance plan and monitor study conduct.
• Prepare and/or review SAP, TFL shells and specifications for variable derivation.
• Collaborate with Statistical Programmers and Clinical Data Manager to address data quality issues.
• Provide statistical and validation support for analysis datasets and TFL.
• Review study reports and regulatory documents; respond to health authorities as needed.
• Coordinate with cross-functional groups and vendors; monitor timelines.
• Oversee CRO activities and CRO deliverables.

Skills

Leadership

Communication

Problem-solving

Education

Ph.D. in Statistics or Biostatistics

MS in Statistics or Biostatistics

Tools

SAS

CDISC

FDA guidelines

Job description

Katalyst CRO in Paramus, New Jersey, is seeking a Senior Manager in Statistics to lead statistical activities across clinical trials from protocol development through final study report. The role requires directing SAS-based analyses, coordinating with statisticians and programmers, and ensuring compliance with ICH, CDISC, and FDA guidelines.

Strong leadership and communication skills are essential to drive timelines and regulatory deliverables.