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Job #03021

About our client Our client is a rapidly growing development-stage pharmaceutical company that is focused on the commercialization of therapeutics for patients with unmet needs that are suffering from chronic kidney disease. With offices in Canada and US, the company boasts a world-class management team with unparalleled expertise in this area, a varied selection of cutting edge protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Manager, Biostatistics Chicago, Illinois or Toronto, Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all quality assurance, technical services and document control functions 2) Formulate analytical strategies and execute company’s core business of pharmaceutical development 3) Participate in clinical and pre-clinical study designs and protocols 4) Coordinate, facilitate and construct appropriate statistical analysis plans and CRFs to support the development plan and are consistent with the requirements for regulatory filings 5) Maintain expertise in state-of-the-art data manipulation and statistical analysis 6) Develop statistical methodology for studies including sample size calculations, randomization schemes and strategy and analysis plan 7) Evaluate databases and statistical analysis programs and interact with computer groups to determine hardware/software compatibility 8) Implement protocol methodology and statistical plan to ensure timely, accurate and consistent analysis 9) Deliver (directly/indirectly) appropriate, accurate as well as understandable line listings and statistical tables 10) Prepare and review statistical sections of study reports and submissions 11) Validate SAS macros and write SAS code 12) Develop program verification procedures and plans to provide thorough and detailed reviews of documentation and analysis output 13) Contribute to development of timelines and budgets within multidisciplinary project teams to ensure timely submissions aligned with company objectives 14) Supervise review of CRFs to issue queries and clean data (as required) 15) Direct database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs 16) Ensure archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs 17) Develop, interact with as well as manage internal employees and external CROs to ensure timely and GxP compliant activities to achieve project success and corporate development plans 18) Participate in regulatory submission process including INDs, CTAs, CTDs and NDAs 19) Serve as statistical interface with the FDA for regulatory submissions and approvals 20) Provide appropriate biostatistical updates to documents 21) Ensure that all documents to be submitted to regulatory agencies are complete, statistically accurate, well-organized and of high quality to facilitate review 22) Build and maintain good business and working relationships with internal as well as external groups 23) Serve as the statistical contact with outside investigators for participation in advisory boards as well as in preparing scientific presentations and manuscripts 24) Lead process improvement, training, standards development or an area of technical expertise 25) Participate in analyzing and reviewing data 26) Edit and contribute to constructing clinical documents (study reports, publications and summaries) 27) Ensure cGCP compliance and accurate presentation of data 28) Provide strategic leadership to identify potential difficulties and strategic execution to implement creative approaches to surmount challenges 29) Participate in activities related to potential in-licensing and out-licensing of products 30) Mentor and manage activities of statisticians and non-statistical peers 31) Provide positive environment to motivate less experienced personnel and communicate statistical concepts to scientists 32) Write statistical documents and data analysis methodology, biometrics as well as descriptive and differential statistics that meet FDA, ICH, AMA Style, CONSORT and GPP publication guidelines Requirements 1) MS/Ph. D. in Biostatistics or Statistics or a related field. 2) 3 – 5 years of pharmaceutical industry clinical development experience (clinical data management) 3) Experience in supporting product approvals and renewals 4) Experience in clinical data management systems a plus 5) Expertise in strategic clinical trial planning and analyses, including experimental design and SAS programming 6) Ability to work independently 7) Ability to be a functional leader as well as a participant in teams 8) Willingness to travel (up to 5%)