Associate Director, Statistical Programming

📋 Description

• Design and code SAS programs for clinical projects (BASE/SAS, SAS/STAT).
• Produce CDISC SDTM and ADaM datasets with specs.
• Develop and deliver TFLs and analysis to meet study/regulatory needs.
• QC SAS code and outputs for SDTM/ADaM datasets and listings.
• Create and review eCTD documents for regulatory submissions.
• Support integrated safety/efficacy datasets and ad hoc analyses.

🎯 Requirements

• MS in Statistics or CS; 6+ years SAS in pharma/biotech.
• BS in Statistics/CS with 8+ years pharma/biotech also considered.
• Proficient in SAS programming.
• CDISC SDTM/ADaM and FDA submission knowledge.
• Working knowledge of R preferred.
• Experience leading programming for early/late phase trials and NDA/MAA.

🎁 Benefits

• Remote work opportunities in the United States.
• Travel to Cambridge, MA several times per year.
• Accommodations available for candidates in the selection process.