Sr. Principal Statistics

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

Job summary

Globalchannelmanagement is seeking a Sr. Principal Statistics in Paramus, New Jersey. The ideal candidate will have 4 years (Ph.D.) or 6 years (MS) in the Pharmaceutical/CRO industry, with extensive knowledge of SAS, ICH guidelines, CDISC data structures, and FDA guidelines. Responsibilities include reviewing protocols, preparing statistical sections, and leading CRO statisticians. Excellent organizational, communication, and interpersonal skills are vital. This role offers the chance to make a significant impact in a dynamic environment.

Qualifications

• 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.
• Exceptional interpersonal skills and problem-solving capabilities.
• Ability to work independently and collaboratively.
• Ability to provide leadership for the CRO statisticians and statistical programmers.

Responsibilities

• Review protocol, understand study requirements, prepare statistical sections.
• Design study elements including sample size calculation, analysis methods, study duration, etc.
• Prepare and/or review SAP, TFL shells and specifications for variable derivation.
• Work closely with Statistical Programmers and Clinical Data Manager to identify data quality issues.
• Provide statistical and validation support for statistical analysis and study report.

Skills

SAS

ICH guidelines

CDISC data structures

FDA guidelines

TFL shells

CRF review

database design review

edit check specifications

sample size calculation

analysis dataset validation

CRO oversight

Education

Ph.D. or MS in Statistics or Biostatistics

Job description

Overview

Sr. Principal Statistics needs 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience.

Qualifications

• SAS, ICH guidelines, CDISC data structures, FDA guidelines, SAP preparation, TFL shells, CRF review, database design review, edit check specifications, sample size calculation, analysis dataset validation, CRO oversight
• Education: 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
• Exceptional interpersonal skills and problem-solving capabilities
• Ability to work independently and collaboratively
• Ability to provide leadership for the CRO statisticians and statistical programmers

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