Senior Biostatistician
Company: Kelly Services
Location: Toronto, ON
General Responsibilities:
 The successful applicant will be responsible for Protocols input, randomization schedule, and database activities
 You will be able to work effectively with the project team to decide on appropriate study design and statistical methodology for routine designs.
 You will be responsible for protocol review.
 This role required the Biostatistician to assist in the development of randomization schedule, sample size and power calculations.
 You would be responsible for assuring that data for statistical analyses are accurate.
 Assists in the implementation of protocol methodology and statistical analysis plans.
 Responsible for the accuracy and timeliness of statistical input into reports or decisions.
 This role assists in the development of alternative analysis strategies when changes to planned analyses are needed, and demonstrates understanding of statistical concepts and methodologies.
 Assists in the development of the Statistical Methods section.
 Responsible for accuracy of statistical tables and data listings, and accuracy of report text.
 Identifies and corrects flaws in interpretation of results, inconsistency in presentation.
 Ensures accuracy of report text and consistency between summary tables in the body of reports and
 the corresponding statistical tables and listings.
 Responsible for statistical methods.
 Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference.
 Works collaboratively with peers to develop quality protocols, CRF, schema, and report per agreed timelines.
 Provides accurate and timely answers to routine questions from clients.
 Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles.
 Can clearly communicate basic statistical concepts to other scientists and non-statisticians.
 Informs supervisor or manager on important issues in a timely manner.
Skills/Requirements
 The successful applicant will have a background in statistics, biometrics and have had experience within a Clinical Research environment. They will also exhibit the following skills.
 High degree of technical competence and communicative ability, both oral and written.
 Competent in experimental design, descriptive and inferential statistics, biometrics and computer systems.
 Good knowledge of ICH/GCP guidelines.
 Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, (Health Canada, FDA).
 MS degree with more than 3+ yrs exp or PhD with 1+ years exp.
 Proficient in SAS programming, preferably SAS certified
 Experience in CDISC standards

If you have the skills and experience required for this position, please forward your resume to: E-mail: shelley.burford@kellyservices.com