• Perform sample size and power calculations
• Review CRFs and edit checks
• Develop SAP and create table, listing, and figure shells
• Perform statistical analysis as defined in SAP
• Able to code complex statistical analyses as needed; familiar with good coding practices
• Lead clinical study with limited oversight
• Interpret results and write sections of documents; present results
• Support project or lead statisticians in preparing for interactions with regulatory agencies
• Assist in regulatory submissions with limited oversight
• Coordinate and supervise work performed by junior biostatisticians
• Read and understand Medical/Clinical literature as required by duties
• Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
• Working knowledge of FDA regulations, ICH GCP guidelines, the drug development process
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• At least 5 years in pharmaceutical/biotechnology clinical trials or related environment - Masters level in Statistics, Biostatistics, Epidemiology or related field
• Good programming skills and knowledge of SAS, knowledge of R a plus
• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
• Able to prioritize work and complete deliverables to timelines with some supervision
• Excellent verbal and written communication skills
• Detail and process oriented
• Oncology experience preferred
Seattle Genetics is an Equal Opportunity Employer.
Seattle Genetics - 10 months ago