A leading Pharmaceutical Company has an opening for a Biostatistician.
A Senior Biostatistician who applies statistical methodologies to clinical and research datasets; assists in protocol design; develops statistical analysis plans; drafts presentations of statistical findings and methods; communicates results to internal and external customers; and provides leadership within the statistical function.
• Provide statistical support for a large ongoing clinical trial in the active surveillance setting in prostate cancer, ProVent.
• Provide statistical support during the development of study protocols in addressing any statistical issues (e.g. sample size calculations, statistical methodology, and statistical analyses)
• Participate in developing detailed statistical analysis plans; conduct research on methodologies; independently assess the appropriateness of statistical methodology; and effectively communicate to stakeholders the reasoning behind the selection of particular methodologies.
• Participate in database design and management meetings to ensure that data are free of bias, contain maximum information (minimum variance), and satisfy analytical requirements. And review Case Report Forms (CRFs) to ensure that all relevant data necessary to planned analyses is captured.
• Analyze data and interpreting results from studies to meet objectives of the study protocol, and business and publication objectives; independently apply and implement basic and complex techniques to these analyses.
• Prepare oral and written reports to effectively communicate results of clinical trials to the project team, senior management, regulatory agencies and/or individual investigators and other external reviewers of clinical trials data. And ensure the scientific integrity of the statistical methodologies applied and findings reported in clinical trials.
• Participate in cross functional teams supporting the conduct of clinical trials and provide the statistical perspective on those teams.
• Communicate effectively with regulatory agencies, in meetings and in written material (e.g. briefing documents) the statistical methodologies and analyses conducted and provide interpretation of the results generated during clinical studies.
• Work independently with minimal supervision and communicate effectively around timelines, status of deliverables and project progress to project team members and other stakeholders.
• PhD/MS degree in Statistics, Biostatistics, or related field and at least 8 to 10 years of relevant experience in the pharmaceutical/biotech industry.
• High level of personal motivation and the ability to work independently.
• Proficiency in SAS Analytics programming
• Ability to provide cross functional support within Clinical and Regulatory Affairs and other departments