Associate biostatistician

7 days ago


Mississauga ON, Canada Pharma Medica Research Inc. Full time

Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for an Associate Biostatistician to join our team in our Mississauga location.
The Associate Biostatistician assists in the statistical analyses of data generated in clinical experiments; assist in the design and development of databases for clinical trials; participate 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 and Statistical Programming and/or designate.

Participate and assist 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.
Help create SAS® programs that will generate listings, tabulations, graphical presentations and summary statistics to support regulatory submissions.
Assist in the statistical/data analyses using SAS® programs on Phase-I Pharmacokinetic (PK), and Comparative Bioavailability (BA) studies.
Work closely with Report Writers to help prepare and review the PK/Stats section of reports in support of ANDA (ANDS) and NDA (NDS) submissions.
Participate and assist in the design, creation and validation of databases for electronic ANDA and NDA submissions.
Interact with clients and PMRI personnel to help 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.
Participate and assist in the development, implementation, and maintenance of the Standard Operation Procedures (SOPs) related to statistical services.
Attend selected scientific and commercial meetings and exhibitions to assist in marketing of PMRI services.
Master’s degree in Mathematics and/or Statistics
~ SAS® programming is an asset
~1 year of experience in statistical analyses
~ Must have excellent computer skills
~ Excellent verbal and written English communication skills
~ 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
Corporate Discounts Program



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    Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for an...


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