Principal Biostatistician

Posted:
4/15/2024, 5:00:00 PM

Location(s):
Ile-de-France, France ⋅ Paris, Ile-de-France, France

Experience Level(s):
Senior

Field(s):
Data & Analytics

Workplace Type:
Remote

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 

  • Provides pastoral care to biostatisticians they are assigned to 

  • Advises other staff and clients on statistical methodology and statistical principles 

  • Supports Quality Assurance in internal and external audits 

  • Supports the Director of Biostatistics in reviewing baseline estimations and Project Plans 

  • Supports in reviewing budget proposals 

  • Conducts other activities as required 

DESIRED QUALIFICATION & EXPERIENCE 

  • Bachelor degree in Statistics 

  • At least 8 years of experience in Biostatistics 

  • SAS Programming

  • ICH E9 Statistical Principles for Clinical Trials, Very Good  

TECHNICAL COMPETENCES & SOFT SKILLS 

  • English, Very Good

  • MS Office Suite, Good

  • Italian speaking language is preferred

Languages

English

Education

Bachelor of Science (BS): Statistics

Contract Type

External

Alira Health

Website: https://alirahealth.com/

Headquarter Location: Paris, Ile-de-France, France

Employee Count: 101-250

Year Founded: 1999

IPO Status: Private

Last Funding Type: Venture - Series Unknown

Industries: Biotechnology ⋅ Consulting ⋅ Health Care