The primary responsibility of the Lead Statistical Analyst is to work independently and assume responsibility for the development and use of standard programs and statistical project data structures for all clinical studies within the assigned Study/Project. Ensures timely creation of TLF package and/or submission data/analysis documentation package according to regulatory guidelines
POSITION DUTIES & RESPONSIBILITIES
Provide statistical programming support for assigned clinical study study/project
Coordinate activities of assigned statistical programming team members
Ensure the development of programs and use of project standards for all analysis datasets, tables, listings and figures for assigned project with close cooperation with the study/project statistician.
Has deep project knowledge, including indication relevant issues. Oncology experience is required.
Participate in the IND/NDA activities, as needed for assigned project.
Support all statistical programming function deliverables required for submissions to regulatory authorities for assigned projects/studies
Works in close cooperation with other Clinical Operations departments
BS/MS/PhD in Statistics, Mathematics, Computer Science or equivalent (of theoretical/technical depth).
5 + years statistical programming with SAS in pharmaceutical or biotech with experience in creating and validating SDTM and/or ADaM data structures.
Oncology experience is required and experience in Oncology efficacy analysis is
Excellent computer skills and database management knowledge
Ability to manage multiple issues and meet & negotiate tight timelines
Project management or equivalent experience would be an asset
- provided by Dice Associated topics: biostatistics, data analyst, probability, statistics, c
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.