Overview

The primary responsibilities of this position are to provide leadership in planning and conducting data analyses in clinical studies, and participate in planning and data analyses for regulatory submission.

Responsibilities

• Provide statistical consulting to clinical study design
• Review study protocols and write statistical sections
• Conduct sample size and power calculations
• Propose randomization methods and designs
• Generate randomization schedules
• Assist in regulatory submission strategy planning
• Participate in study team operations and timeline discussion
• Identify issues, and provide solutions to clinical operation and data management for issues that potentially impact data analyses
• Review and provide comments to statistical analysis plans that are written by the 3rd party
• Develop statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions
• Review programming specifications and provide high level input to derivation rules for data integration.
• Provide high level input to 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
• Prepare statistical sections of clinical study reports 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

Qualifications

Education

• Master's or Doctoral degree in statistics or biostatistics

Experience

• Master's degree with 4-8 years or Doctoral degree with 2-6 years of relevant experience in a health sciences research institute or the pharmaceutical/biotech industry
• Direct participation in design, planning, conduct, analyses, and reporting of clinical trials

Skills

• Deep understanding on statistical methodology related to clinical trials and drug development
• Basic knowledge on regulatory guidelines
• Working knowledge of SAS
• 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.