Senior Principal Statistical Programmer

Katalyst CRO; Paramus (NJ); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Katalyst CRO seeks a Senior Manager in Statistics in Paramus, NJ, to lead statistical activities across clinical trials from protocol through final study report and regulatory filings. The role requires expert SAS skills, strong knowledge of ICH/CDISC and FDA guidelines, and leadership of CRO statisticians and programmers.

The role emphasizes collaboration with cross-functional teams, timely delivery, and oversight of statistical programming and data quality.

Formación

• Proficiency with SAS software.
• Familiarity with ICH, CDISC, and FDA guidelines.
• Strong organizational and time-management skills.
• Ability to lead CRO statisticians and programmers.

Responsabilidades

• Review protocols and design study elements including sample size calculations and analysis methods.
• Review CRFs, database design, and edit check specifications.
• Monitor study conduct and ensure quality surveillance.
• Prepare or review SAPs and specifications for data derivation.
• Collaborate with statisticians, programmers, and data managers to resolve data quality issues.
• Provide statistical support for analyses and validation.
• Review study reports and regulatory documents.
• Contribute to responses to health authorities.

Conocimientos

SAS

ICH Guidelines

CDISC Data Structures

FDA Guidelines

Communication

Leadership

Educación

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Descripción del empleo

Summary of Position:

The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.

Summary

Summary of Position:

The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.

Responsibilities

Duties and Responsibilities:

• Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.
• 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
• Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
• Provide statistical and validation support for statistical analysis, analysis datasets and TFL
• Review study report, manuscripts and other documents related to statistics
• Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents
• Perform other ad-hoc statistical activities as needed
• Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming
• Participates in monitoring CRO activities and reviewing CRO deliverables
• Other duties as assigned

Must have:

• Ph.D or MS in Statistics or Biostatistics
• Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
• Excellent knowledge of SAS computer package
• Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines
• Excellent organizational skills, time management, and ability to meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others
• Ability to work independently and problem-solve
• Ability to provide leadership for the CRO statisticians and statistical programmers