Biostatistician II

Summary

Join Precision Medicine Group as a Biostatistician and provide statistical support throughout all phases of clinical development. You will be responsible for tasks such as reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. This role requires a Master's or PhD in a relevant field with experience in SAS and knowledge of industry standards. Preferred qualifications include experience with Oncology and rare diseases. The position offers a competitive salary, annual bonus, health insurance, retirement savings, life and disability insurance, parental leave, and paid time off.

Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 2+ years experience; PhD degree in Statistics, Biostatistics, or related field
• Experience with SAS
• Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

Responsibilities

• Generate randomization schedules
• Assist with statistical methods review of the clinical study protocol under close supervision of senior biostatistician or above
• Provide and/or verify sample size calculations
• Provide input into development of case report forms (CRFs)
• Author statistical analysis plans, including development of table, figure and listing shells
• Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
• Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
• Provide programming support and assist with statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
• Assist with statistical consulting tasks under close supervision of senior lead biostatistician or above
• Review output across programs to ensure consistency under close supervision of senior biostatistician
• Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded statistician under close supervision of senior biostatistician
• Review statistical sections of clinical study reports
• Work directly with sponsors, project managers, and external vendors on statistics-related project components
• Interact directly with study team
• Interact directly with sponsors
• Assist with completion of statistical activities for study within timelines
• Provide units for development of monthly project invoices
• Train and mentor new biostatisticians
• Assist with bid defense meetings
• Other duties as assigned

Preferred Qualifications

Experience with Oncology and rare disease

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation