Sr. Manager/Associate Director, Statistical Programming
Tasks
- Archive software outputs and analysis files
- Attend multidisciplinary team meetings
- Create and review programming plans
- Create software test plans
- Develop and support statistical programming team
- Develop software systems for tables listings graphs
- Develop software validation procedures
- Ensure quality statistical programming deliverables
- Lead statistical programming activities
- Maintain clinical data analysis SOPs
- Manage Statistical Programming team
- Manage critical deadlines
- Oversee contract programmers and vendors
- Prepare TLGs for regulatory submissions
- Prepare datasets for NDA and BLA submissions
- Provide input to CRFs
- Provide input to SAPs
- Provide input to data management plan
- Provide time and resource estimates
- Review clinical reports and related documents
- Serve as programming lead on studies
- Suggest algorithms for analysis requests
Perks/Benefits
- 401k match
- Dental insurance
- Health insurance
- Paid Holidays
- Paid time off
- STD/LTD
- Sick leave
- Vision insurance
Skills/Tech-stack
BLA | CDISC | Clinical Data Analysis | Clinical data | Data Analysis | Drug development | EMA | FDA | JavaScript | NDA | NMPA | PMDA | Project Management | R | S&OP | SAS | Software validation | Statistical programming | Table Listing Graph | Test Plan
Education
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