POSITION SUMMARY The primary responsibilities of this position are to lead study level statistical related activities, particularly to write statistical analysis plans, prepare mock tables/figures/listings, and generate statistical analyses for clinical studies.
ESSENTIAL JOB FUNCTIONS
Review study protocols and write statistical sections
Conduct sample size and power calculations
Generate randomization schedules
Review case report forms to ensure appropriate data collection
Review edit checks algorithm to ensure data quality for statistical analyses
Participate in study team operations and timeline discussion
Provide solutions to clinical operation and data management for issues that potentially impact data analyses
Assist review and provide input to statistical analysis plans that are written by the 3 rd party
Prepare statistical analysis plans
Prepare mock tables, figures, and listings
Review programming specifications and work with statistical analysts/programmers to prepare CDISC compliant SDTM and ADaM datasets
Conduct inferential statistical analyses and check model adequacy of statistical analyses
Perform statistical validation/quality control on analyses generated by statistical analysts/programmers
Conduct ad-hoc analyses and data mining
Write statistical reports for results interpretation if needed
Participate in clinical results interpretation meetings
Work with medical writers to assist with clinical study reports preparation
Work with project managers to ensure timely and high quality delivery of analysis packages
Experience and Education Doctoral degree with 0-2 years of relevant experience in statistical analyses
Skills • Good understanding in statistical concepts and methods • Working knowledge of SAS and/or R • Good interpersonal and communication skills
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.