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Job #03149

About our client Our client has a heart for those with cardiovascular ailments. The company is developing new therapies for atrial arrhythmia and other heart conditions. Its lead drug candidate is vernakalant hydrochloride used for treating acute and chronic atrial arrhythmia. Position Location Biostatistician Vancouver, British Columbia Salary Highly competitive package, commensurate with experience Responsibilities 1) Collaborate with physicians, other statisticians, and clinical research scientists on Phase I-IV clinical programs including designing of clinical trials 2) Develop statistical analysis strategies and prepare study reports and regulatory submissions 3) Oversee appropriate designing, development and implementation of sound statistical methodology, comprehensive protocol reviews, sample size calculation and randomization for assigned studies 4) Ensure all work is of adequate quality and consistency within project requirements 5) Oversee validity of alternative analysis strategies when unforeseen circumstances arise 6) Oversee the development and automation (where appropriate) of statistical analysis and reporting for clinical programs 7) Identify and correct flaws in interpretation of results and inconsistencies in presentation or inference 8) Collaborate and partner with other team members in a multidisciplinary setting 9) Serve non-statistical peers with regard to basic statistical methodology and departmental operations 10) Work well under pressure, with initiative to take on unfamiliar tasks Requirements 1) Ph. D. with at least 2 years of relevant experience 2) Experience in PK/PD analyses by quantitative modeling and simulation 3) Experience in analyzing variance, linear and non-linear mixed effect models, survival analysis, Bayesian analysis, trial simulation, categorical data analysis, multivariate analysis and nonparametric techniques 4) Experience in individual, average and population PK analyses, bio-equivalence, bio-availability 5) Knowledge of adaptive design concepts and methodology, preferably with an emphasis on biomarker applications for both pre-clinical and clinical studies 6) Good knowledge of and experience in computing tools such as S-Plus/R, NONMEM and SAS 7) In-depth knowledge of global regulatory guidance documents and requirements 8) Effective communication skills (written and oral)