Senior Statistician

Katalyst CRO; Edison (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Manager in Statistics to oversee statistical activities in clinical trials. The ideal candidate will hold a Ph.D or MS in Statistics/Biostatistics with significant experience in the Pharmaceutical/CRO industry, particularly in SAS and regulatory standards. Responsibilities include reviewing protocols, designing studies, and leading cross-functional teams. Excellent communication and organizational skills are essential for success in this role.

Qualifications

• Ph.D or MS in Statistics or Biostatistics required.
• 4+ years for Ph.D or 6+ years for MS in the Pharmaceutical/CRO industry.
• Excellent knowledge of industry standards like ICH guidelines and CDISC.

Responsibilities

• Perform statistical activities in clinical trials from start to finish.
• Review protocols, study requirements, and design study elements.
• Work with CRO activities and monitor study conduct.

Skills

Statistical analysis

SAS

Communication

Problem-solving

Leadership

Education

Ph.D or MS in Statistics or Biostatistics

Tools

SAS

Job description

Overview

Job Description The Senior Manager in Statistics responsible for performing 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.

Requirements

• 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.