To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02825

About our client Our client is a leading pharmaceutical company specializing in pain therapy. They have close to 5,000 employees globally and have a developed a reputation as a leading innovator in the field. With operations in approximately 30 countries and a 70-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer. Position Location Biostatistical Expert New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide statistical input at clinical project and study level 2) Plan, analyze and report the biostatistical part of a clinical project and/or study, including the introduction and implementation of biostatistical methods 3) Represent the statistical aspects of a project to regulatory authorities and in the scientific community 4) Provide clinical input for regulatory documents 5) Cooperate with CROs 6) Provide trial-related calculations in alignment with the overall clinical strategy 7) Recommend resource needs and analysis costs for trials 8) Work according to ICH-GCP and ICH-biostatistics’ guidelines 9) Instruct and supervise SAS programmers 10) Contribute to other activities of the Clinical Core Team and Study Team as defined in the respective team profiles Requirements 1) Degree (4 year) in Mathematics/Statistics, Biometry or equivalent 2) Minimum 3 years of experience as a Biostatistician for a pharmaceutical/biotech company 3) Practical experience in Mathematics/Statistics or Biometry 4) In-depth knowledge of biostatistical methods 5) Knowledge of relevant guidelines 6) Good understanding of medicine and drug safety to optimize design of studies in cooperation with specialists from other disciplines a plus 7) Familiarity with relevant aspects in clinical research and regulatory processes