Principal / Associate Director, Statistical Programming
PA - Conshohocken - Office, United States
USD 180K-219K Mid-level Full Time
Tasks
- Collaborate with biostatistics clinical data management regulatory operations and clinical teams
- Coordinate CRO programming deliverables to meet timelines and quality
- Develop and maintain programming standards macros automation QC procedures SOPs and working instructions
- Develop validate and maintain SAS programs
- Lead statistical programming activities across clinical studies
- Participate in process improvement and automation initiatives
- Review CRO deliverables including SDTM ADaM TLF Definexml and submission packages
- Support regulatory submissions including NDA BLA and pooled analyses
Perks/Benefits
- 401k match
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible paid time off
- Life insurance
- Medical insurance
- Vision insurance
Skills/Tech-stack
ADaM | Automation | CDISC | Clinical Trial Data | Clinical trial | DefineXML | QC procedures | R | S&OP | SAS | SAS Macro | SDTM | Statistical Analysis | TLF | Trial data
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
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