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.
Field, California
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