Senior Biostatistician
Location: Canada
Job Category: Biostatistics
Time Type: Full-time
Posted on: 8 Days Ago
Apply Now
About ProPharma:
ProPharma has been at the forefront of advancing patient health and wellness for over 20 years. Our expertise spans across biotechnology, pharmaceutical, and medical device industries, offering customized consulting solutions that help our clients accelerate their drug and device programs while ensuring compliance with industry standards.
Position Overview:
ProPharma is seeking a Senior Biostatistician to lead statistical activities for clinical trials, data analysis, and the development of statistical analysis plans. The successful candidate will collaborate closely with cross-functional teams and ensure the accuracy and quality of statistical deliverables.
Key Responsibilities:
Lead statistical activities in clinical trials, including study design, statistical analysis plan development, and execution of statistical analysis.
Provide statistical expertise to clinical operations, data management, and regulatory affairs teams.
Ensure quality control and accuracy of statistical deliverables such as reports, tables, listings, and graphs.
Collaborate on the development and review of clinical study protocols and case report forms (CRFs) to ensure alignment with appropriate statistical methods.
Develop and maintain SAS programs for statistical analysis, following SOPs, good programming practices, and regulatory guidelines.
Stay updated with regulatory guidelines and industry standards related to biostatistics.
Assist in the development and enhancement of internal processes and SOPs to improve statistical efficiency.
Provide guidance and mentorship to junior statisticians.
Qualifications:
Educational Requirements:
Ph.D. in Biostatistics, or M.S. in Biostatistics.
Experience Requirements:
3+ years of relevant work experience.
Experience in the outsourcing industry is required.
Proven experience in clinical trial design, sample size calculations, and statistical analysis.
Familiarity with CDISC data structures (SDTM, ADaM).
Skills and Abilities:
In-depth knowledge of statistical methodologies and their application in clinical trials.
Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
Strong project management skills and the ability to handle multiple projects simultaneously.
Experience with SAS and/or R programming.
Knowledge of regulatory requirements related to statistical analysis and reporting of clinical trial data.
Workplace Commitment:
ProPharma values diversity, equity, and inclusion and strives to provide a workplace where every individual can thrive. We encourage innovative, collaborative, and entrepreneurial thinking, offering a safe space for all employees to succeed.
Additional Information:
ProPharma does not accept unsolicited resumes from recruiters or third-party agencies.
No phone calls or emails regarding this posting, please.
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