Senior Principal Statistical Programmer

Katalyst CRO; Paramus (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading clinical research organization in Paramus, NJ is seeking a Senior Manager in Statistics to oversee statistical activities in clinical trials. The ideal candidate will have a Ph.D. or MS in Statistics and at least 4 to 6 years of experience in the pharmaceutical sector. Responsibilities include designing study elements, reviewing statistical analysis, and interacting with cross-functional teams to ensure quality and compliance. Strong knowledge of SAS and industry standards is essential, along with excellent organizational and communication skills.

Qualifications

• Minimum of 4 years (Ph.D.) or 6 years (MS) Pharmaceutical/CRO industry experience.
• Excellent knowledge of industry standards such as ICH guidelines and CDISC data structures.
• Ability to work independently and problem-solve.

Responsibilities

• Review protocol and prepare statistical sections of studies.
• Work closely with Statistical Programmers and Clinical Data Manager.
• Participate in monitoring CRO activities and reviewing CRO deliverables.

Skills

SAS computer package

Leadership

Communication

Time management

Problem-solving

Education

Ph.D. or MS in Statistics or Biostatistics

Job description

Overview

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

• 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.

Qualifications

• 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.