Offer summary

Qualifications:

MSc degree in Statistics or equivalent experience., At least 8 years of experience in Biostatistics., Proficient in SAS Programming and a broad range of statistical methodologies., Strong understanding of ICH E9 Statistical Principles for Clinical Trials..

Key responsabilities:

Prepare and review Statistical Analysis Plans and specifications.

Write and review statistical methodology and results sections of reports.

Provide statistical input to the design and review of Protocols and Case Report Forms.

Conduct training sessions on statistical methodology for internal and external staff.

Job description

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Principal Biostatistician takes responsibility of the projects he/she is assigned to, meeting the timelines and the standards of quality agreed for deliverables and keeps good communication both externally with the clients for technical aspects and internally with the team and the project manager

The Principal Biostatistician prepares the Statistical Analysis Plans, writes the statistical methodology and the results sections of reports, provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings for other staff and clients on statistical methodology and statistical principles.

KEY RESPONSABILITIES

Prepares and reviews Statistical Analysis Plans and specifications
Writes and reviews the statistical methodology and results sections of reports
Performs sample size calculations
Review of Statistical analysis (tables, figures and listings) of clinical trials
Provides support to DMC/DSMB charter preparation
Participates to DMC/DSMB meeting as independent statistician
Provides statistical input to the design and review of Protocols and Case Report Forms
Writes Blind Review plans and reports
Participates and conducts Blind Review meeting
Prepares and performs training to internal/external staff on statistical methodology and statistical principles
Writes and reviews statistical parts of scientific articles
Creates SAS programs for Datasets and TLFs validation
Reviews the specifications for analysis datasets
Manages the technical communications with client
Provide leadership for all biometrics activities on assigned projects
Provides mentoring and coaching to other biostatisticians
Advises other staff and clients on statistical methodology and statistical principles
Conducts other activities as required