About The Role
Serves as the statistical lead for multiple clinical studies, representing Biometrics on one or more study management teams. Provides statistical direction and support for study design, analysis, and reporting to expedite the conduct and evaluation of clinical trials and basic research. Performs statistical analysis of clinical trial data.
Your Contributions
- Represents Biometrics on one or more study management teams
- Collaborates on clinical study protocols, statistical analysis plans, and clinical study reports
- Identifies experimental designs and defines analysis endpoints; develops randomization plans and statistical methods
- Reviews database data validation specifications, data review plans, coding guidelines, and data transfer agreements
- Prepares statistical analysis plans for approval
- Partners with statistical programmers to ensure correct implementation and to develop summary table/figure/listing specifications
- Monitors and reports CRO performance of statistical analyses/programming
- Provides biostatistical support to nonclinical, medical affairs, and commercial areas
- Assists with SOPs, templates, data standards, and selection/implementation of statistical software
- Develops and implements new statistical methods as needed
- Performs other duties as assigned
Requirements
- Masterβs in statistics/biostatistics (or related) + 4+ years relevant experience OR PhD preferred + 2+ years relevant experience
- Solid clinical study design, analysis, and reporting expertise; strong SAS programming (incl. relevant SAS procedures)
- Knowledge of CDISC and FDA standards for SDTM/ADaM
- Broad knowledge of regulatory guidelines; experience with regulatory authority interactions highly desirable
- Strong project management, organization, communications, problem-solving, analytical thinking; detail-oriented and able to meet multiple deadlines
Benefits (included)
- Retirement savings plan (company match), paid vacation/holiday/personal days, caregiver/parental leave, medical leave, and health benefits (medical, prescription drug, dental, vision)
Compensation (included)
- Annual base salary $110,800β$151,000; annual bonus target 20% of earned base salary; equity-based long-term incentive eligibility