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Biostatistician II - Job Opportunity at Precision Medicine Group

Remote, Canada
Full-time
Mid-level
Posted: July 27, 2025
Remote
CAD 85,000 - CAD 110,000 annually. This estimate reflects the mid-level positioning of a Biostatistician II role in the Canadian market, considering the 2+ years experience requirement, advanced SAS programming responsibilities, and direct sponsor interaction duties. The remote nature may allow for competitive positioning across major Canadian markets, with potential for performance-based increases given the mentoring and consulting responsibilities included in the role.

Benefits

Comprehensive remote work flexibility enabling optimal work-life balance and access to global opportunities without geographical constraints
Professional development through mentoring responsibilities and exposure to diverse clinical trial phases
Collaborative environment with direct sponsor interaction providing valuable industry networking opportunities
Equal opportunity employment ensuring fair treatment and career advancement based on merit

Key Responsibilities

Lead randomization schedule generation ensuring robust statistical foundation for clinical trial integrity and regulatory compliance
Drive statistical methodology review for clinical protocols under senior guidance, contributing to study design optimization and scientific rigor
Execute and validate critical sample size calculations that determine study feasibility and statistical power for regulatory submissions
Influence case report form development through statistical expertise, ensuring optimal data collection for analysis objectives
Author comprehensive statistical analysis plans including shell development, establishing the analytical framework for successful study outcomes
Generate analysis datasets, tables, figures, and listings using SAS programming, creating deliverables that support regulatory submissions and medical decision-making
Provide quality control oversight for statistical programming and documentation, ensuring compliance with regulatory standards and sponsor requirements
Deliver specialized programming support for regulatory agency requests and exploratory analyses, contributing to product approval strategies
Support statistical consulting initiatives under senior supervision, building expertise while contributing to business development
Ensure cross-program consistency through output review processes, maintaining quality standards across multiple concurrent studies
Serve as unblinded statistician for Data Monitoring Committees, providing critical safety and efficacy analyses that guide study continuation decisions
Review and validate statistical sections of clinical study reports, ensuring accurate representation of study findings for regulatory submissions
Manage direct stakeholder relationships with sponsors, project teams, and vendors, building trust and ensuring successful project delivery
Drive timely completion of statistical deliverables within project timelines, supporting overall study milestones and commercial objectives
Lead training and mentorship of junior biostatisticians, contributing to team development and knowledge transfer

Requirements

Education

Master's degree or equivalent in Statistics, Biostatistics, or related field with 2+ years experience; PhD degree in Statistics, Biostatistics, or related field

Experience

2+ years experience

Required Skills

Experience with SAS Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines Understanding of statistical concepts and techniques, such as inference, analysis of variance, linear models, regression, survival analysis, non-parametric analysis, estimation, hypothesis testing, and statistical modeling Understanding of clinical trial concepts, such as randomization, hypothesis testing, estimation of treatment effects, sample size calculation, etc. Ability to do advanced statistical analyses, program tables and graphs, and perform data transformations Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines Excellent communication and interpersonal skills to effectively interface with others Excellent problem-solving skills Excellent presentation skills Experience with Oncology and rare disease
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Sauge AI Market Intelligence

Industry Trends

The clinical research industry is experiencing unprecedented growth driven by personalized medicine initiatives, with biostatisticians becoming increasingly critical for precision medicine applications and companion diagnostic development. The integration of real-world evidence and complex biomarker strategies requires sophisticated statistical expertise, positioning biostatisticians as key strategic contributors rather than purely analytical support roles. Remote work has become permanently embedded in clinical research operations, with companies like Precision Medicine Group leading the distributed workforce model. This trend has expanded talent pools globally while requiring enhanced digital collaboration skills and regulatory compliance in virtual environments, fundamentally changing how statistical teams operate and deliver results. Regulatory agencies are demanding more sophisticated statistical approaches for rare disease and oncology trials, including adaptive designs, Bayesian methods, and innovative endpoints. This shift requires biostatisticians to possess deeper therapeutic area expertise and the ability to navigate complex regulatory pathways, making specialized knowledge in oncology and rare diseases increasingly valuable. The adoption of CDISC standards and electronic submissions has become mandatory across the industry, with regulatory agencies requiring standardized data formats for all submissions. Biostatisticians must now be proficient in data standardization processes and electronic submission requirements, making technical compliance skills as important as statistical methodology expertise.

Role Significance

Biostatistician II roles typically operate within statistical teams of 8-15 professionals, reporting to senior biostatisticians or statistical directors while potentially supervising 1-2 junior team members or statistical programmers. The mentoring responsibilities suggest involvement in team development, indicating a pivotal position that bridges junior and senior levels within the statistical organization.
This Biostatistician II position represents a solid mid-level role with significant growth trajectory, evidenced by the combination of independent statistical analysis plan authoring, direct sponsor interaction, and mentoring responsibilities. The role balances guided supervision for complex tasks with independent execution of core biostatistical functions, indicating a position designed for professionals ready to advance from junior to senior levels while building comprehensive clinical trial expertise.

Key Projects

Lead statistical support for Phase II and Phase III oncology and rare disease trials, including complex adaptive designs and innovative endpoint development that directly impact regulatory approval strategies and patient access to innovative therapies Drive statistical analysis plan development for precision medicine studies involving companion diagnostics and biomarker-driven patient selection, requiring integration of genomic data and personalized treatment approaches Support regulatory submissions including FDA and Health Canada filings, preparing statistical sections of clinical study reports and responding to regulatory questions that determine product approval outcomes Collaborate on Data Monitoring Committee analyses for safety and efficacy assessments, providing critical insights that guide study continuation decisions and patient safety protocols

Success Factors

Mastery of advanced SAS programming techniques combined with deep understanding of regulatory requirements will be essential for producing compliant, high-quality statistical deliverables that meet both sponsor expectations and regulatory standards. Success requires the ability to translate complex statistical concepts into actionable insights for cross-functional teams and regulatory bodies. Strong project management and stakeholder communication skills will be critical given the direct sponsor interaction and cross-functional collaboration requirements. The ability to manage multiple concurrent studies while maintaining quality standards and meeting aggressive timelines will distinguish high-performing candidates in this competitive field. Continuous learning and adaptation to evolving regulatory landscapes, particularly in oncology and rare disease therapeutic areas, will be necessary for long-term success. The precision medicine focus requires staying current with innovative statistical methodologies and regulatory guidance while building therapeutic area expertise. Leadership and mentoring capabilities will be increasingly important as the role involves training junior staff and contributing to team development. The ability to balance individual contributor responsibilities with team leadership functions will be essential for career advancement within the organization.

Market Demand

High demand with competitive market conditions. The clinical research industry faces a significant shortage of qualified biostatisticians, particularly those with SAS expertise and regulatory knowledge. The combination of growing clinical trial volumes, increased complexity in statistical methods, and the specialized nature of precision medicine creates strong job security and advancement opportunities for qualified candidates.

Important Skills

Critical Skills

Advanced SAS programming proficiency is absolutely essential as it serves as the primary tool for all statistical analyses, data manipulation, and regulatory submission preparation. Mastery of SAS enables efficient handling of complex clinical trial data and ensures compliance with industry standards for statistical programming and validation. Deep understanding of ICH guidelines, CDISC standards, and FDA regulations forms the foundation for all clinical trial statistical work, ensuring that analyses meet regulatory requirements and support successful product approvals. This regulatory knowledge directly impacts the validity and acceptability of statistical deliverables. Statistical methodology expertise including survival analysis, linear models, and hypothesis testing provides the analytical foundation necessary for designing appropriate analyses and interpreting complex clinical trial results. These skills enable appropriate selection of statistical methods and accurate interpretation of treatment effects. Project management and communication skills are critical given the direct sponsor interaction, cross-functional collaboration, and timeline management responsibilities. These skills ensure successful project delivery and stakeholder satisfaction in a client-service environment.

Beneficial Skills

Therapeutic area expertise in oncology and rare diseases enhances value proposition and career advancement opportunities, as these areas require specialized knowledge of disease progression, clinical endpoints, and regulatory pathways that general biostatisticians may lack Experience with adaptive trial designs and Bayesian methods represents emerging industry trends that will become increasingly important as sponsors seek more efficient and flexible clinical development strategies Programming skills in R or Python complement SAS expertise and provide flexibility for exploratory analyses, data visualization, and integration with emerging data science methodologies that are becoming more prevalent in clinical research Knowledge of real-world evidence methodologies and health economics outcomes research expands analytical capabilities beyond traditional clinical trials, supporting the growing industry focus on demonstrating real-world effectiveness and economic value

Unique Aspects

The combination of precision medicine focus with comprehensive biostatistical responsibilities offers exposure to cutting-edge therapeutic development including companion diagnostics, biomarker strategies, and personalized treatment approaches that represent the future of drug development
Direct involvement in Data Monitoring Committee support as unblinded statistician provides rare exposure to real-time safety and efficacy assessment, offering invaluable experience in clinical trial oversight and regulatory decision-making processes
The mentoring and training responsibilities embedded within a mid-level role indicate accelerated leadership development opportunities, allowing for skill building in team management and knowledge transfer while maintaining individual contributor focus
Remote work arrangement combined with direct sponsor interaction creates unique professional networking opportunities across geographical boundaries, potentially providing access to diverse therapeutic areas and international regulatory experience

Career Growth

Career progression typically occurs every 2-4 years in the clinical research industry, with high-performing biostatisticians advancing more rapidly due to industry demand. The combination of technical expertise, regulatory knowledge, and leadership experience gained in this role provides strong foundation for advancement to senior positions within 3-5 years.

Potential Next Roles

Senior Biostatistician positions with increased autonomy in statistical methodology selection and study design consultation, typically achieved within 2-3 years with strong performance and continued therapeutic area specialization Statistical Team Lead or Principal Biostatistician roles involving broader project oversight and team management responsibilities, representing natural progression for candidates who excel in the mentoring and stakeholder management aspects of the current role Regulatory Affairs Statistical Reviewer positions with health authorities or consulting roles with regulatory strategy firms, leveraging the deep regulatory knowledge and submission experience gained in this position Director of Biostatistics roles within mid-size CROs or pharmaceutical companies, combining statistical expertise with business development and strategic planning responsibilities

Company Overview

Precision Medicine Group

Precision Medicine Group operates as a specialized clinical research organization focused on precision medicine and personalized healthcare solutions, positioning itself at the intersection of advanced therapeutics and companion diagnostics. The company's emphasis on precision medicine indicates involvement in cutting-edge clinical trials involving biomarker-driven patient selection, genomic medicine, and innovative therapeutic approaches that represent the future of drug development.

As a focused precision medicine CRO, the company occupies a specialized niche within the broader clinical research market, likely competing with larger organizations like IQVIA and Syneos Health while differentiating through therapeutic area expertise and specialized capabilities. The precision medicine focus suggests strong relationships with biotech companies and pharmaceutical firms developing targeted therapies.
The remote Canada positioning suggests the company is expanding its North American operations while maintaining flexibility in talent acquisition. This approach allows access to Canada's strong life sciences talent pool while supporting both domestic Health Canada submissions and international regulatory strategies.
The remote-first approach combined with direct sponsor interaction suggests a collaborative, results-oriented culture that values flexibility while maintaining high professional standards. The emphasis on mentoring and professional development indicates investment in employee growth and knowledge sharing, typical of specialized organizations that rely on deep expertise and long-term employee retention.
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