Senior Clinical Biostatistician - Design to Analysis Leader

Alsinova; Waterloo; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Experience accelerator

Diverse projects for clients

Tailored career path

Continuous learning

Inclusive work environment

Résumé du poste

Alsinova is seeking an experienced Clinical Statistician to lead studies from design through execution within a CRO framework. The role emphasizes statistical strategy, protocol input, and robust analysis planning in collaboration with project teams.

Ideal candidates have 3–5 years Biostatistics experience, strong SAS skills, and familiarity with ICH/EMA/FDA guidelines; CDISC ADAM is a plus, and excellent English is required.

Qualifications

• 3–5 years experience in Biostatistics in pharmaceutical/CRO environments.
• Strong knowledge of international guidelines (ICH, EMA, FDA).
• Knowledge of CDISC ADAM is a plus.
• Good level of English.

Responsabilités

• Manage a study from design to execution, across various designs.
• Establish study strategy using statistical methods (power modelling, scenarios).
• Monitor and implement mitigation plans to minimize statistical risk.
• Provide input to protocol design, endpoints, randomization, and sample size.
• Develop SAP and coordinate reviews; review TFLs with statisticians; QC analysis methods.
• Validate study datasets and analysis programming specs; approve deviations from TFL formats.
• Propose conclusions for Statistical Analysis Results and respond to stat questions.

Connaissances

Interpersonal skills

Global study process view

English proficiency

Outils

SAS software

Description du poste

Alsinova is seeking an experienced Clinical Statistician to lead studies from design through execution within a CRO framework. The role emphasizes statistical strategy, protocol input, and robust analysis planning in collaboration with project teams.

Ideal candidates have 3–5 years Biostatistics experience, strong SAS skills, and familiarity with ICH/EMA/FDA guidelines; CDISC ADAM is a plus, and excellent English is required.