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Eupraxia Pharmaceuticals
Victoria, British Columbia, Canada (hybrid)
13 days ago

Description

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 onsite or remotely within Canada.

 Job Description:

The CDMB role will contribute to data management and statistics activities in support of studies across all stages of pre-clinical and clinical drug development, providing expertise and support for Eupraxia’s clinical development programs, as well as for any related investigator-initiated studies. Working within the environment of a biopharma company, handling in-house data work and review of vendor work.

Reports to:  Head of Clinical

Responsibilities:

  • Data Management
    • Act as the first line of contact for Data Management (DM) at the project level
    • Review CRO DM plans, CRF and database design, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation
    • Provide input into DM related activities associated with regulatory inspections/audits
    • Provide DM standards expertise for regulatory submissions including INDs and NDAs
    • Oversee compliance to Trial Master File requirements relating to DM Vendor 
  • Statistics:
    • Act as the first line of contact for Statistics at the project level
    • Provide 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 data requirements
    • Generate QC programs to check TFLs, and program TFLs when needed
    • Perform sample size and power calculations
    • Independently, and at request, provide exploratory and illuminating analysis of complex data
    • Interact with regulatory authorities to resolve statistical issues relating to analysis and reporting of clinical trials and regulatory submissions, acting as statistical representative at meetings with regulatory authorities 
  • CRO Management:
    • Maintain excellent relationships with pharmaceutical partners and CRO partners
    • Coordinate vendor timelines and milestone deliverables on assigned projects related to DM and Statistics
    • Ensure DM and Statistics billing is accurate and gives recommendations for payment of invoices
    • Coordinate DM and Statistics Vendor performance
    • Identify risks and collaborate with the DM and Statistics Vendors to mitigate risks
    • Provide technical expertise when working with CROs
    • In general, ensure that Vendor DM and Statistics provides accurate and robust data and subsequent analysis
    • Support Project Management in ensuring plans are updated and aligned over time. 
  • Organization and Planning:
    • Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
    • Represent DM and statistical requirements related to strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
    • Support GCP inspection readiness 
    • Demonstrate clear alignment with Core Values including Teamwork, Innovation, Openness and Excellence 
  • Publications / Presentations:
    • Write 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
    • Plan and write regulatory submission materials such as the appropriate sections of INDs, or integrated summaries of efficacy and safety
    • Contribute to other publications and presentations as necessary.


Requirements

  • BS/BA in scientific discipline with over 4 years related experience in a pharmaceutical/CRO setting
  • Broad knowledge of the drug development process and clinical study designs
  • Ability to successfully lead simultaneous trials and meet deadlines while working with external partners
  • Demonstrated experience of clinical databases, different clinical DM systems and electronic data capture (EDC)
  • Strong knowledge of eClinical processes
  • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
  • 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 and understanding of regulations and industry-adopted data standards, such as CDISC, SDTM, and CDASH and SEND
  • Experience using standardized medical terminology, including MedDRA and WHODrug
  • In-depth knowledge of statistical and sample size methodologies and software.
  • Experience with query management process and reconciliation activities
  • Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project
  • Good communication and interpersonal skills including effective problem solving
  • Ability to work independently in a global team environment
  • Highly motivated and flexible, with excellent organizational and time management skills
  • Experience in interacting with regulatory authorities on statistical issues relating to PK data, clinical trials and regulatory submissions

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.

How to Apply:

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

Job Information

  • Job ID: 65750774
  • Workplace Type: Hybrid
  • Location:
    Victoria, British Columbia, Canada
  • Company Name For Job: Eupraxia Pharmaceuticals
  • Position Title: Senior Manager, Clinical Data Management & Biostatistics
  • Industry: Biotechnology
  • Job Function: Clinical Data Manager
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 3-5 Years
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

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