Senior clinical biostatistician

Overview

Med-Life Discoveries (MLD) is a clinical-stage biopharma company developing novel lipid-based therapies for the treatment of conditions including Rhizomelic chondrodysplasis punctata (RCDP) and other neurological conditions.

MLD is seeking a motivated and highly experienced Senior Clinical Biostatistician to lead the statistical analysis of natural history data with the objective of building an endpoint selection strategy for a Phase II clinical trial. The successful candidate will have extensive experience (≥10 years) in biostatistics within the biotechnology or pharmaceutical industry, including prior engagement with the U.S. Food and Drug Administration (FDA), and a deep understanding of regulatory guidances for clinical endpoint selection and the use of natural history data as external (non-concurrent) control groups.

This position reports directly to the CEO. The successful candidate is expected to independently build statistical models and make recommendations for suitable endpoints and endpoint strategies, and be able to defend them at in-person FDA meetings. The position can be primarily remote, however some travel to MLD's headquarters in Saskatoon and the FDA in the United States will be required.

Key Responsibilities & Duties

• Lead statistical analyses of small-N, prospective natural history datasets including repeated measures, clinical assessments, physiological indices, and patient-reported outcomes (PROs).
• Design and execute longitudinal data analyses to characterize disease trajectory, variability, and progression.
• Develop, validate, and document novel composite or indexed measures of disease severity when existing endpoints are insufficient.
• Perform comprehensive data analysis using statistical software such as R, Python, MATLAB, and GIS tools.
• Collaborate with clinical, data management, and regulatory teams to define statistical analysis plans (SAPs) compliant with FDA guidance.
• Prepare statistical sections for regulatory submissions, briefing packages, and participate directly in FDA Type C meetings and other regulatory interactions.
• Apply and interpret a broad range of statistical methodologies including but not limited to:
• Mixed-effects (hierarchical) models for repeated measures
• Longitudinal trajectory modeling
• Nonlinear regression and spline fitting
• Principal component analysis (PCA) and factor analysis
• Multivariate analysis of variance (MANOVA)
• Time-to-event and survival analyses
• Bootstrap and resampling methods for small-N data
• Correlation and regression analyses for biomarker–endpoint relationships
• Item response theory (IRT) or Rasch modeling for questionnaire/QOL data
• Sensitivity analyses and missing-data imputation
• Integrate clinical, physiological, and patient-reported outcomes into cohesive endpoint justification packages.
• Communicate statistical findings clearly to technical and non-technical audiences, including FDA reviewers and clinical investigators.
• Design and implement data collection strategies to ensure high-quality, reliable datasets for research purposes.
• Assist in the development of research protocols and contribute to scientific publications.
• Prepare detailed reports, visualizations, and presentations of analytical results for stakeholders.

Qualifications

Required:

• Master's or PhD in Biostatistics, Statistics, Epidemiology, or a related quantitative discipline.
• Minimum of 10 years' experience in the pharmaceutical or biotechnology industry.
• Proven record of FDA interactions, including authorship of briefing packages and in-person participation in Type B/C meetings.
• Deep familiarity with FDA guidances on:
• Use of natural history data as external controls
• Endpoint selection and validation in rare diseases
• Statistical principles for small-population trials
• Demonstrated experience with small-sample, prospective, longitudinal clinical data.
• Proficiency in R, SAS, or JMP, and experience with data visualization and reproducible reporting tools (R Markdown, ggplot, etc.).
• Strong communication and documentation skills suitable for regulatory submissions.

Preferred experience:

• Experience in rare disease or ultra-rare pediatric studies.
• Familiarity with data standards (CDISC, SEND) and FDA/EMA electronic submission formats.
• Previous involvement in endpoint qualification or development of composite clinical scales.
• Experience collaborating in cross-functional, remote teams.
• Bachelor's or Master's degree in Biostatistics, Statistics, Data Science, or a related field; Ph.D. preferred.
• Proven experience in data analysis, research methodologies, and statistical modeling.
• Strong proficiency in statistical programming languages such as R, Python, MATLAB, and GIS software.
• Experience with data collection processes within laboratory or field settings is highly desirable.
• Excellent analysis skills with the ability to interpret complex datasets accurately.
• Laboratory experience or familiarity with scientific research environments is a plus.
• Strong communication skills for presenting technical information clearly to diverse audiences.
• Ability to work independently as well as collaboratively within a team environment.

Job Type: Full-time

Pay: $145,000.00-$195,000.00 per year

Benefits:

• Casual dress
• Dental care
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• Vision care
• Wellness program
• Work from home

Work Location: Hybrid remote in Saskatoon, SK S7N 2X8