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Senior Manager Biostatistics - Eupraxia Pharmaceuticals

Location
Victoria, BC
Details
Full Time
2 days ago
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.

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Additional Info

Job Type : Full-Time

Location : Remote, Victoria, BC

Experience Level : Senior Level
Category
Biotechnology