Principal Biostatistician

Alira Health

Remote, Europe

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