Principal Statistical Programmer
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Job Description
Principal Statistical Programmer at Everest Clinical Research leading complex statistical programming and validation projects in clinical trials. Coordinating teams and ensuring quality deliverables in the FDA submissions.
Responsibilities:
- Lead projects with higher level of complexity/challenges/difficulties
- Lead efforts to resolve complex statistical programming issues or problems
- Perform a leadership role in statistical programming projects
- Assist statistical programming management in properly planning and allocating resources
- Participate in developing and maintaining clinical trial data and statistical programming standards
- Perform hands on primary statistical programming and validation programming on assigned projects
- Create SDTM mapping specifications and ADaM data specifications
- Perform quality control (QC) review of these documents prepared by others
- Create SDTM and ADaM define.xml files
- Provide training, mentorship, and technical guidance to less experienced Statistical Programmers
Requirements:
- M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields
- 10 (M.Sc., M.A.)/9 (Ph.D.) years’ related experience
- in-depth knowledge of clinical trial data processing and manipulation
- hands on statistical programming and analysis
- knowledge of industry standards
- regulatory and ICH requirements
- proficiency in SAS programming
- in-depth understanding of standardization in data,
- strong leadership and drive to achieve goals
Benefits:
- medical, dental, and vision coverage
- life & AD&D insurance
- short- and long-term disability
- tuition reimbursement
- fitness reimbursement
- employee assistance program (EAP)
- a 401(k) retirement
- generous paid time off and sick leave
- the opportunity to earn a performance based bonus
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