Senior Director, Statistical Programming
Tasks
- Collaborate with Biostatistics Data Management Clinical Operations Regulatory and Pharmacovigilance
- Develop and maintain SAS programming infrastructure processes and data standards
- Develop data review reporting tools and statistical applications
- Drive process improvements using automation and AI solutions
- Implement statistical programming processes standards and SOPs for clinical trials
- Lead programming activities for assigned projects and studies
- Mentor and develop programmers
- Oversee CROs and external vendors to ensure quality and compliance
- Provide expert programming input on study documents
- Provide hands on support for complex analyses and ad hoc requests
- Review SAPs DMPs CRFs annotated CRFs and TFL specifications
- Review and validate SAS programs including SDTM ADaM and TFLs
Perks/Benefits
Skills/Tech-stack
ADaM | Artificial Intelligence | Automation | BLA | Biostatistics | CDISC | Clinical Data Analysis | Clinical data | Clinical data standards | Clinical trials | Controlled Terminology | Data Analysis | Data Management | Data Standards | Data review | EMA | FDA | ICH Guidelines | MAA | NDA | R | Regulatory Submissions | SAS | SDTM | Statistical programming | TFL
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