Senior Biopharmaceutical Statistician

About Us Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary polymer-based micro-sphere technology, enables targeted drug delivery with extended duration and hyper-localized delivery to tissues physicians want to treat. The technology aims for fewer adverse events through precision targeting and stable, flat delivery of the active ingredient, potentially augmenting and transforming existing FDA-approved drugs to improve safety, tolerability, efficacy and duration of effect. Potential uses may extend beyond pain and inflammatory GI disease to oncology, infectious disease and other critical disease areas. Company Projects Eupraxia\'s EP-104GI is in a Phase 1b/2a RESOLVE trial for eosinophilic esophagitis (EoE). EP-104GI is injected into the esophageal wall for local drug delivery. Eupraxia recently completed a Phase 2b trial (SPRINGBOARD) of EP-104IAR for knee osteoarthritis pain, meeting its primary endpoint and three of four secondary endpoints. The company is developing a pipeline of later and earlier-stage long-acting formulations targeting inflammatory and oncology indications. For more details, visit Job Description We are seeking a sharp, flexible, and innovative Senior Biostatistician to lead the statistical strategy for clinical development programs and oversee data management. This is a hands-on, high-impact role ideal for someone who thrives in a fast-paced biotech environment and contributes to programs from early development through submission. The successful candidate will bring advanced modeling and statistical expertise, creative problem-solving, and strong leadership abilities. You will play a central role in clinical trial design, data interpretation, regulatory submissions, and data-driven decision-making. Reports to : Chief Medical Officer Key Responsibilities Statistical Leadership: Serve as the lead statistician across multiple clinical trials (Phase 1–3). Design and drive statistical strategy for clinical development plans and regulatory submissions. Develop protocols, statistical analysis plans (SAPs), and randomization strategies. Contribute to and defend key statistical components in regulatory filings (IND, NDA, BLA). Oversee statistical programming, analysis, and validation (in-house or outsourced). Deliver high-quality study reports and exploratory analyses that unlock value beyond primary endpoints. Modeling & Simulation Build and apply advanced statistical and PK/PD models to support dose selection, trial optimization, and forecasting. Run pre-study scenarios using Bayesian and frequentist approaches. Integrate real-time data to guide ongoing clinical decision-making. Data Visualization & Communication Create impactful, theory-informed visualizations. Leverage interactive graphics to surface insights for internal and external stakeholders. Translate complex findings into clear narratives for diverse audiences. Data Management Oversight Provide strategic and operational oversight of the data management function. Ensure data integrity, consistency, and audit readiness across studies. Collaborate with internal and CRO data teams to build scalable systems and processes. Cross-functional Collaboration Work with Clinical Operations, Medical/Pharmacovigilance, Regulatory Affairs, Medical Writing, and external partners. Support executive decision-making with statistical insight and data-driven recommendations. Mentor junior staff and foster a culture of scientific rigor and continuous improvement. Qualifications Required Ph.D. or M.Sc. in Biostatistics, Statistics, or a related field. 5–8+ years of industry experience in clinical trial biostatistics. Deep understanding of clinical trial design, ICH/GCP guidelines, and regulatory standards. Hands-on experience with SAS and R; familiarity with modern data science tools a plus. Experience with regulatory interactions, presentations, and submission support. Proven ability to drive statistical strategy and influence key stakeholders. Preferred Experience in oncology, rare disease, rheumatology, gastroenterology, or inflammation/immunology. Experience supporting later-stage regulatory filings including NDA or MAA. Familiarity with adaptive designs, Bayesian methods, and model-informed drug development. Exposure to omics analysis, data mining, or real-world data integration. Strong presentation skills and ability to communicate with executives and regulators. Additional Attributes Intellectually curious, adaptable, and creative. Strategic and hands-on—attention to detail and big-picture thinking. Strong sense of ownership and accountability. Clear communicator, collaborative team player, and natural problem solver. Passionate about innovation in biostatistics and making an impact on patient care. Salary & Benefits Salary Range: CAD$ 190,000 – 230,000 annually. Within the posted range, pay is determined by skills, experience, and education. A performance-based bonus is available, along with a competitive benefits package. How To Apply Please send your CV and cover letter to Shortlisted candidates will be notified. Thank you for your submission. Additional Information Seniority level: Mid-Senior level | Employment type: Full-time | Job function: Research, Analyst, and Information Technology | Industry: Biotechnology #J-18808-Ljbffr