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Job #03612

About our client Our client is a well-known company that provides clinical trial services in drug dispensing clinical trial subject randomization and data management. Position Location Senior Biostatistician Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide statistical input into Case Report Forms (CRF) design for assigned projects 2) Develop, apply and/or provide expertise in statistical and data management methods and techniques 3) Enable decision-making in support of the company’s mission, strategies, customers and priorities 4) Assume project management responsibilities in directing and managing statistical as well as data management team activities for clinical trials from the development of study protocols to the completion of study reports 5) Represent division and the company 6) Provide leadership in executing divisional and corporate plans 7) Participate in business development and customer relationship management activities 8) Provide leadership/expertise in resolving complex problems in support of divisional/company objectives, assigned projects or as a consultant to others 9) Investigate and implement new technologies, processes and procedures 10) Provide leadership/expertise in research and development of statistical methodologies 11) Develop and execute marketing strategies and plans (trade shows, publications/presentations, corporate website design and maintenance, meeting with existing and new clients) 12) Write Statistical Analysis Plans for assigned projects 13) Participate in new business development and bidding processes 14) Develop and execute customer relationship management plans 15) Review clinical study protocols and statistical/data management documents generated by others 16) Act as Lead Biostatistician/Liaison Biostatistician to interact with clinical trial sponsor companies 17) Oversee projects for a sponsor company and/or for given therapeutic areas 18) Lead assigned projects by applying project management skills, statistical and data management techniques to facilitate better decision-making 19) Improve business operations, discover, improve, develop or defend new or existing products 20) Plan, develop and monitor timelines for statistical and data management activities in accordance with medical/clinical activities for assigned projects 21) Assess statistical and data management resource needs jointly with immediate management and manage the assigned resources 22) Provide statistical and data management input into protocol development 23) Oversee IVRS or web-based patient randomization processes for assigned projects 24) Provide statistical input into Case Report Forms design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRF 25) Oversee the development of Data Management Plans (DMPs) for assigned projects 26) Provide statistical and programming input into database design for assigned projects 27) Oversee efforts in development, validation and testing of the study databases 28) Participate in study manual development, clinical trial initiation meetings such as investigator meetings and site monitor/coordinator training sessions 29) Address statistical and data management questions/concerns from the meeting participants 30) Train site personnel on data management requirements and procedures 31) Oversee data management activities for assigned projects 32) Serve as primary contact between medical/clinical and data management in data-related issues 33) Validate the accuracy, consistency and integrity of the statistical output displays generated by the study programmer 34) Oversee programming support activities for assigned projects 35) Perform statistical data analyses 36) Write statistical and data management sections of the joint medical and statistical study reports for assigned projects 37) Archive study documentation upon the completion of final study reports with assistance from the archivist 38) Participate in evaluating the performance of assigned project personnel 39) Follow up on the development and implementation of new statistical and data management methodologies 40) Provide specialized training in an area of technical, professional or business expertise 41) Lead efforts in the development, maintenance and adherence to divisional SOPs and guidelines 42) Participate and contribute to the training and development of new biostatisticians 43) Lead efforts in the development, maintenance and adhere to therapeutic area specific standards and conventions and be the primary knowledge holder of sponsor specific requirements 44) Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants 45) Lead efforts in the development, maintenance and adherence of corporate policies and SOPs 46) Plan and carry out professional development Requirements 1) Ph. D. or equivalent in Statistical Science, Mathematical Analysis or a related field or a master's degree 2) Minimum 8 years of relevant experience 3) Knowledge of SAS, Datafax and Oracle 4) Ability to interact with clinical trial sponsor companies 5) Ability to write Statistical Analysis Plans for assigned projects 6) Ability to provide input to Case Report Forms (CRF) designs for assigned projects 7) Good presentation and written communication skills 8) Superb process management and negotiation skills 9) Good decision-making skills