Lead Biostatistician

Found in: Jooble CA O C2 - 2 weeks ago


Toronto ON, Canada SCiAN Services Full time

SCiAN Services is a Contract Research Organization offering expertise-based services in the Biotechnology/ Pharmaceutical Industry. SCiAN serves well known companies by providing high quality deliverables and superior customer service. For over 34 years we have embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions. In your position, you will be introduced to all areas of expertise ranging from Biostatistics to Data Management to IT. As Lead Biostatistician , you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on any of the following: Immunology, Early Development, Medical Affairs, Oncology, and Infectious Disease studies. Working collaboratively with the STATs and CDM groups, you will ensure high quality statistical deliverables.

Reviewing CRFs and data review guidelines, developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.
Performing statistical analyses and interpreting statistical results.
assessing impact of protocol amendments and DB design changes on SAP, SDTM and ADaM package; Reviewing draft and production statistical output, responsible for quality and consistency of output across multiple cycles.
Recommend statistical methodology to analysis of clinical trial data.
PhD strongly desired.
Experience working for a Contract Research Organization.
Therapeutic experience in Oncology, CNS, Medical Affairs, Immunology or orphan drug indications strongly desired.
Proven experience leading Statistical Projects.
Solid knowledge and application of CDISC, SDTM and ADaM submissions.
Excellent oral and written English skills. 
Proficiency in Microsoft Office suite (Word, Excel, Power Point);
Strong organizational, communication, time management and multi-tasking skills;
Good knowledge of good clinical practices, and applicable local and international regulations/guidelines.
To find out more about SCiAN Services and to review other opportunities, please visit our website at 


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