Biostatistician

7 days ago

Mississauga, Ontario, Canada Pharma Medica Research Inc. Full time $80,000 - $120,000 per year

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people's lives. Come join our team

We are currently looking for a Biostatistician to join our team in Mississauga

The Biostatistician performs statistical analyses of data generated in clinical experiments; participate in study design and interpretation of study results. The Biostatistician contributes to the design and development of databases for clinical trials, participates in data management and data validation for Phase I-IV clinical studies as necessary at Pharma Medica Research Inc (PMRI). This position reports to the Manager, Biostatistics & SAS Programming and/or designate.

Responsibilities:

  • Participates in the development of study designs including power and sample size calculation, design/review of study case report forms, preparation of statistical analysis plans and randomization schemes for PK, BA/BE studies and/or clinical trials.
  • Creates SAS programs that will generate listings, tabulations, graphical presentations and summary statistics to support regulatory submissions.
  • Assists in maintaining, optimizing and validating existing SAS programs for Phase I-IV and BA/BE studies.
  • Performs statistical/data analyses using SAS programs on Phase I Pharmacokinetic (PK), and Comparative Bioavailability (BA) studies.
  • Works closely with Report Writers to prepare and review the PK/Stats section of reports in support of ANDA (ANDS) and NDA (NDS) submissions.
  • Participates in the design, creation and validation of databases for electronic ANDA and NDA submissions.
  • May interact with clients and PMRI personnel to provide statistical advice on safety and efficacy evaluation for BA/BE studies and clinical trials which meet regulatory standards in Canada, US and EU countries.
  • Participates in the development, implementation, and maintenance of the Standard Operation Procedures (SOPs) related to statistical services.

    Other duties as assigned.

We offer:

  • Competitive compensation plan
  • A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan
  • Opportunities for advancement and career progression
  • A generous Employee Milestones Awards Program
  • Corporate Discounts Program
  • Learning Support Programs
  • Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.

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