Senior Biostatistician

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the resolution of daily work-related challenges and issues.

• Ensure the quality, efficiency, and productivity of statistical and programming operations.

• Manage assigned projects utilizing project management, statistical, and programming skills.

• Deliver project outcomes with a focus on quality and timely execution.

• Provide statistical expertise in the design, analysis, and reporting of clinical trials and research projects.

• Contribute to the development of study protocols, sample size calculations, randomization specifications, and randomization codes.

• Draft Statistical Analysis Plans and address comments from peer statisticians during reviews.

• Establish and maintain quality control (QC) and quality assurance (QA) plans for statistical and programming tasks.

• Develop and assess ADaM dataset specifications, while offering insights on SDTM specifications.

• Conduct QC validation for analysis datasets, tables, listings, and graphs (TLGs).

• Lead statistical dry runs and final runs; manage project resources and resolve data-related issues with data management.

• Review Analysis Data Reviewer’s Guides and integrate reviewer feedback.

• Execute statistical analyses and validations in accordance with Statistical Analysis Plans (SAPs).

• Plan or contribute to meetings for reporting and disseminating trial results.

• Assist in the development and review of Clinical Study Reports, ensuring accuracy, completeness, and proper statistical interpretation.

• Compose statistical reports or the statistical sections of Clinical Study Reports (CSRs).

• Conduct statistical analyses for publications, abstracts, manuscripts, presentations, and posters.

• Provide statistical input for CRF design, database structures, data collection, data cleaning, and data validation.

• Specify or program database quality acceptance checks and address data quality issues until resolved.

• Support data management and trial management teams in the preparation for database lock.

• Complete all mandatory and project-specific training programs.

• Adhere to company and trial sponsor policies, SOPs, and work instructions.

• Archive study files in accordance with sponsor requirements.

• Plan and execute professional development activities.

⛳️ Requirements

• Ph.D. in statistical science, mathematical analysis, or a related field with 2 years of relevant experience, or a Master’s degree with 4 years of highly relevant experience.

• Proven ability and consistent performance.

• Statistical expertise in designing, analyzing, and reporting on clinical trials and research projects.

• Experience with sample size calculations and randomization specifications/codes.

• Capability to write Statistical Analysis Plans (SAPs).

• Experience in creating and maintaining Statistical and Programming Quality Control (QC) and Quality Assurance (QA) Plans.

• Familiarity with developing and/or reviewing ADaM dataset specifications.

• Background in reviewing SDTM dataset specifications.

• Experience in QC validation of analysis datasets and TLGs.

• Proficient in statistical analysis, validation, and reporting for Clinical Study Reports (CSRs).

• Experience in conducting statistical analyses for publications, including abstracts, manuscripts, presentations, and posters.

• Ability to provide statistical input for CRFs, database structures, data collection, data cleaning, and data validation specifications.

• Capacity to comply with relevant company and sponsor policies, SOPs, and work instructions.

• Skill in properly archiving study files.

• Ability to plan and implement professional development activities.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life & AD&D insurance.

• Short-term disability.

• Long-term disability.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off.

• Sick leave.

• Opportunity to earn a performance-based bonus.

• Option for home-based remote work in accordance with the Work from Home policy.