Job Description:
• Implement and execute methodological and statistical aspects of clinical studies
• Manage biostatistical activities related to drug product development for assigned clinical studies
• Collaborate with study teams internally and with clients
• Manage study timelines and resources
• Ensure quality, accuracy, and compliance of statistical analysis output
• Perform descriptive and inferential analysis of clinical data
• Provide statistical assistance in clinical trials
• Collaborate with Clinical Research and Medical Writing groups on protocols, case report forms, statistical analysis plans, and study documents
• Write, validate, and work on biostatistical programs for statistical analysis plans, statistical analysis, and derived analysis datasets
• Develop, revise, and/or review SOPs relating to biostatistical services
• May provide statistical expertise for submission of marketing applications to FDA, EMEA, or other worldwide regulatory agencies
Requirements:
• Bachelor’s degree with 4-5 years of experience OR Master’s degree with 3-4 years of experience in Statistics, Mathematics, Biostatistics, Data Science, or a related quantitative field
• Excellent communication skills
• Good programming skills in SAS, S-plus or other statistical software
• Ability to work in a team environment
• Knowledge of concepts and methodologies of QA and relevant regulatory requirements
• In-depth knowledge of FDA and ICH guidelines and regulations
• Knowledge of industry data standards, e.g., CDISC, SDTM and ADaM
Benefits:
• 401k Employer Match with immediate vesting
• Vision Insurance
• Medical and Dental Insurance with multiple coverage options
• FSA (Medical, Dependent Care, and Commuter)
• Short Term Disability
• Long Term Disability
• Life Insurance
• Generous Paid Holidays and PTO