Sr. Biostatistician - BioMarin Pharmaceutical (Novato, CA)
BioMarin Pharmaceutical Inc. At BioMarin, we recognize and value each employee s contribution toward reaching our corporate mission to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them. Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us. EEO/M/F/D/V To apply: Visit www.BMRN.com Job Code 09-0111 SUMMARY DESCRIPTION The overall function of Biostatistician is to provide a statistical support to new drug development project teams through actively participating in protocol development (study design, sample size justification, and safety/efficacy analysis methods) and developing a statistical analysis plan and programming specifications in preparing a clinical study report (CSR) or publication. RESPONSIBILITIES Participate in new drug development programs as a Subject Matter Expert (SME) in statistics area. Keep abreast with advanced statistical analysis methods and results/data presentation formats of clinical data. Collaborates with Medical Monitor, Clinical Research Associate (CRA), Medical Writer, Clinical Data Management (CDM), and Statistical Programmer in developing a clinical study protocol, case report forms (CRFs), and edit checks. Provides a sample size based on the specification provided by Medical Monitor. Develops a statistical analysis plan for a clinical study or publication. Develops analysis specifications for Statistical Programmer and reviews/verifies analyses and programming codes for quality assurance. Participates in development of standard reporting programs for clinical studies. Participates in development of standard CRFs for clinical data collection. Participates in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA Ensures the quality of data and accuracy of analyses in regulatory submissions (e.g., CSR) or publications. Develops SOPs, guidelines, and template.
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