Principal Statistical Programmer (Remote)
Bridgewater, New Jersey, United States; Remote, United States
R
USD 112K-175K Senior-level Full Time
Tasks
- Assign and follow up programming tasks
- Coordinate study teams and timelines
- Create ADaM data specifications
- Create SDTM mapping specifications
- Create define.xml files
- Develop clinical trial data and statistical programming standards
- Develop statistical programming policies SOPs guidelines
- Ensure quality of programming deliverables
- Interact with clients
- Lead complex statistical programming projects
- Lead programming efforts for drug development programs
- Monitor compliance with data and programming standards
- Participate in project bidding or bid defense
- Perform 3rd level QC review of deliverables
- Perform QC review of SDTM and ADaM documents
- Perform QC review of regulatory submission programming
- Perform statistical programming and validation
- Plan and perform archival of programming datasets and outputs
- Provide training and mentorship
- Represent company in sponsor interactions
- Resolve statistical programming issues
- Transfer archived files to clinical trial sponsors
Perks/Benefits
- 401k retirement
- Dental insurance
- Employee assistance program
- Fitness reimbursement
- Life insurance
- Long-term disability
- Medical insurance
- Paid time off
- Short-term disability
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
ADaM | Clinical Study Standards | Clinical Trial Data | Clinical data | Clinical data standards | Clinical study | Clinical trial | Clinical trial data management | Data Management | Data Quality | Data Standards | Data Validation | Data quality control | Define-XML | DefineXML | GxP | ICH requirements | Quality Control | Regulatory Submissions | S&OP | SAS | SDTM | Statistical programming | TLG
Education
Regions
Countries
States
Cities
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