As a Principal Biostatistician, you will join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing :
* Serve as the responsible biostatistician on clinical trials.
* Contribute to clinical study protocols.
* Develop Statistical Analysis Plans and/or perform senior quality review of statistical analysis plans.
* Review and interpret results from simple to complex clinical studies.
* Provide input in the development and review of CRFs.
* Perform lead review and QC of TFLs.
* Critically review derived datasets specifications and datasets (ADaM).
* Present key results.
* Contribute to clinical study reports.
* Review randomization specifications and schemes.
* Oversee outsourced trials from a Biostatistics perspective.
* Contribute to press releases and scientific publications.
You are :
* PhD in statistics, biostatistics, or related field with 5+ years of experience in CRO or pharmaceutical companies OR a Master’s degree with 10+ years of experience.
* Thorough knowledge of CDISC standards and regulatory requirements.
* Experience with Phase 2 and 3 studies.
* Proficiency in R programming, ESTIMANDS, adaptive designs, and writing SAPs.
* Experience in analysis creation for publications.
* Strong leadership and communication skills.
* Knowledge of ADaM and TFL programming.
Why ICON?
We offer a comprehensive reward package, including competitive pay, variable incentives, and employee benefits. We are committed to continuous learning and professional development. ICON is an equal opportunity employer dedicated to a discrimination-free workplace. If you require accommodations during the application process, please let us know. We encourage all qualified individuals to apply, regardless of whether you meet every requirement.
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