Senior Biostatistician

ProPharma; Windsor; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading consulting firm is looking for a Senior Biostatistician to lead statistical activities for clinical trials in Windsor, Canada. The ideal candidate will have a Ph.D. or M.S. in Biostatistics and at least 3 years of relevant experience. Responsibilities include providing statistical expertise, developing SAS programs, and ensuring the quality of statistical deliverables. This is a full-time position offering a collaborative environment and a chance to make a significant impact on clinical research.

Qualifications

• Deep knowledge of statistical methodologies.
• Excellent communication and interpersonal skills.
• Strong project management skills.
• Knowledge of regulatory requirements for statistical analysis.

Responsibilities

• Lead statistical activities for clinical trials.
• Provide statistical expertise to cross-functional teams.
• Ensure quality of statistical deliverables.
• Participate in development and review of clinical study protocols.
• Develop and maintain SAS programs for statistical analysis.

Skills

Statistical methodologies

Communication and interpersonal skills

Project management

Regulatory requirements knowledge

SAS and/or R programming

Education

Ph.D. or M.S. in Biostatistics

Tools

SAS

R

Job description

Join to apply for the Senior Biostatistician role at ProPharma.

ProPharma has spent the past 20 years improving patient health and wellness by providing expert advice that empowers biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies. The company partners with clients through an advise-build-operate model across the entire product lifecycle. With expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers customizable consulting solutions to de-risk and accelerate high-profile drug and device programs.

Essential Functions

• Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.
• Provide statistical expertise to cross-functional teams, including clinical operations, data management, and regulatory affairs.
• Ensure the quality and accuracy of statistical deliverables, including reports, tables, listings, and graphs.
• Participate in the development and review of clinical study protocols and CRFs to ensure appropriate statistical analysis.
• Develop and maintain SAS programs for statistical analysis in accordance with SOPs, good programming practices, and regulatory guidelines.
• Stay updated on regulatory guidelines and industry standards related to biostatistics and ensure compliance.
• Contribute to the development and maintenance of internal processes and SOPs to improve statistical efficiency and consistency.
• Provide guidance and mentorship to junior statisticians.
• Other duties as assigned.

Necessary Skills and Abilities

• Deep knowledge of statistical methodologies.
• Excellent communication and interpersonal skills, capable of working collaboratively across teams and with external partners.
• Strong project management skills to handle multiple projects simultaneously.
• Knowledge of regulatory requirements for statistical analysis and reporting of clinical trial data.
• Proficiency in SAS and/or R programming.

Educational Requirements

• Ph.D. or M.S. in Biostatistics.

Experience Requirements

• Minimum 3 years of relevant work experience.
• Experience in the outsourcing industry.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Familiarity with CDISC data structures such as SDTM and ADaM.

ProPharma values diversity and inclusion, fostering a workplace where everyone can be their authentic selves. We are committed to equity and provide a safe, empowering environment for all employees.

Note: ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please do not contact via phone or email regarding this posting.

Additional Information

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Research, Analyst, and Information Technology

Industry: Business Consulting and Services

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