Principal Statistician - Job Description - Version 1

Sep 13, 2026

Uploaded by Levi

Principal Statistician provides expert leadership for clinical trials data reporting and regulatory-oriented statistical activities across multiple projects, potentially spanning different phases and therapeutic areas. Responsibilities cover leading complex studies end-to-end, partnering in protocol development, estimating sample size and statistical methodology, and serving as primary sponsor contact for all statistics. The role includes authoring and reviewing statistical analysis plans, performing document and dataset specification reviews, validating efficacy analysis datasets using SAS, supporting safety monitoring committees, and contributing to integrated clinical/statistical reporting. It also supports proposals, training, mentoring, and other operational objectives.

LanguageEnglish

CategoryLetters

FormatPDF

Pages2

Reading Time1 min

AccessFree to download

Tasks and Responsibilities

Reporting and Leadership

Protocol and Sponsor Engagement

Statistical Documentation and Programming

Safety Monitoring and Integrated Reporting

Business Development and Training

Minimum Qualifications and Experience

Principal Statistician –Job Description Job Description Work with the Management Team to ensure Plus-Project provides excellent statistical services. Responsible for managing and leading in-house projects potentially across different phases and therapeutic areas and providing statistical input to single or multiple clinical trials. Support Plus-Project’s provision of statistical consultancy services as required. Tasks and Responsibilities • Reporting into the Management Team, Principal Statisticians provide expert leadership to internal and external study teams in the reporting of clinical trials data, regulatory submissions, safety updates and publications. • Act as lead statistician for multiple projects with any level of complexity. • Collaborate in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol. • Act as the primary contact with the sponsor for all statistics related activities on assigned projects. • Perform statistical review of relevant study documentation ([i.e. case](i.e. case) report form, randomisation specification) and clinical study reports. • Author and review Statistical Analysis Plans (SAPs) based on the protocol, including development of output shells for tables, figures and listings. • Statistical review of dataset specifications. • Programming and validation of efficacy analysis datasets and associated tables, figures and listings. • Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development. • Prepare key portions of the integrated clinical/statistical report, ISS and ISE, including sections related to data handling and statistical methodology, patient accountability, baseline compatibility, and efficacy results. • Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Training: o Prepare statistical courses and train internal staff as required o Supervise, mentor and line manage statisticians • Support internal objectives • Any other reasonable requests at the CEO/Operations Director’s discretion. Minimum qualifications and experience • At least 8 years’ experience • Master's Degree or Ph. D in Statistics (or related discipline) • Significant relevant experience with drug development statistical analysis • Strong project leadership experience • Ability to apply knowledge of statistical design, analysis and programming techniques used in clinical trials • Proficiency in SAS programming • Excellent oral and written communication skills Signatures Employee: Line Manager: Date: Date:

FAQs

What are the principal responsibilities of the Principal Statistician?

The role leads internal and external study teams in reporting clinical trial data, regulatory submissions, safety updates, and publications. It also leads projects, authors/reviews statistical analysis plans, performs statistical reviews, and supports integrated clinical/statistical reporting.

How does the Principal Statistician contribute to protocol development?

The Principal Statistician collaborates on protocol development by selecting an appropriate study design, applying statistical methodologies, calculating sample size to meet a specified power, and writing the statistical sections of the protocol.

What qualifications are required for this position?

The role requires at least 8 years of experience, a Master’s Degree or Ph.D. in Statistics (or related discipline), significant experience with drug development statistical analysis, strong project leadership, and proficiency in SAS programming, plus excellent communication skills.

Sep 13, 2026

Uploaded by Levi