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Senior Manager Biostatistics - Eupraxia Pharmaceuticals

Senior Manager Biostatistics - Eupraxia Pharmaceuticals

Biotechnology Jobs


About Us:

Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products. 

We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork and are eligible to work in Canada.  


Job Description:

The Senior Manager, Biostatistics is responsible for providing in-house statistical expertise and support for Eupraxia’s clinical development programs, as well as for related investigator-initiated studies.


Reports to:  CSO


Responsibilities: 

    Providing expert statistical advice in the design and review of analysis and reporting plans of clinical trials, integrated summaries and other regulatory documents, investigator-initiated study proposals and independent Data Safety Monitoring Board (DSMB) data requirements

    Writing statistical study design sections of clinical protocols, statistical analysis plans, mock Table and Figure Listings (TFLs), study committee data requirements, study reports and/or other reports, regulatory submission materials such as integrated summaries 

    Provides support to clinical trial teams and leads overall study analysis team, including coordination of SAS programmers and statistical consultants as needed

    Develops project-wide strategies, conventions, and procedures for analysis, contributing to processes and SOP development relevant to the position

    Statistical review and authorization of protocols and amendments, including proposed investigator-initiated trials and study committee data requirements, as well as regulatory submission materials such as integrated summaries of data

    Generating QC programs to check TFLs, and programming TFLs when needed

    Modeling of data; sample size and power calculations

    Interacting with regulatory authorities to resolve statistical issues relating to analysis and reporting of clinical trials and regulatory submissions, acting as Eupraxia’s statistical representative at meetings with regulatory authorities

    Supervising external consultants and/or CROs in the provision of programming and statistical services, including contributing to the formulation and implementation of internal and external statistical resource strategies, managing such service providers for the programming, statistical analysis and reporting of clinical trials and integrated summaries; managing the development of statistical analysis plans and mock TFLs; providing technical expertise for programming issues in working with CROs; ensuring quality programming to generate accurate TFLs coordinating peer review of statistical documents

    Developing, prioritizing and meeting measurable short-term and long-term objectives and delivering to predetermined budgets and timelines 

    Maintaining awareness of overall developments in the field of clinical research and in particular expertise in state-of-the-art data manipulation and statistical analyses

    Maintaining excellent relationships with pharmaceutical partners and CRO partners

    Supports Data Management activities and provides guidance on management of clinical data.  


Requirements:

    Expertise and experience in clinical trial design, statistical methodology, and analysis and reporting of clinical trial data and integrated summaries for regulatory submissions 

    Broad knowledge of the drug development process and clinical study designs

    In-depth knowledge of statistical and sample size methodologies and software including SAS

    Experience in programming and generating TFLs, and in generating QC programs to check TFLs 

    Experience with the supervision of CROs and consultants providing programming and statistical analysis services

    Knowledge of current FDA/EMEA/ICH regulatory requirements for the statistical analysis and reporting of clinical trial data and integrated summaries for regulatory submissions

    Knowledge of current data management processes, tools and policies preffered 

    Experience in interacting with regulatory authorities on statistical issues relating to clinical trials and regulatory submissions

    Degree in related subject filed, (Masters or PhD degree) preferred, with a 5-10 years related experience 

    Ability to set and communicate goals, overcome obstacles and achieve results within budget and timeline specifications

    Organizational, interpersonal and communication abilities

    Team building and team-oriented approach; willing to contribute at all levels; high ethical standards and integrity


This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits, and career development opportunities. 

While only short-listed candidates will be notified, we thank each applicant for their submission. 


Additional Info

Job Type : Full-Time

Location : Remote, Victoria, BC

Experience Level : Senior Level

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