Lead Statistical Programming: SDTM/ADaM Expert

Kardigan; San Francisco (CA); On-site; USD 172,000 - 234,000; Full time

Job summary

Kardigan in South San Francisco, CA or Princeton, NJ, is seeking a Senior Manager of Statistical Programming to lead programming activities, perform hands-on analyses using SAS and R, and review deliverables for in-house and outsourced work. The role bridges Biostatistics and CDM, helps develop CRFs and standards, and leads NDA eSubmission and define.xml generation while mentoring a cross-functional team and collaborating with CROs.

Qualifications

• Master’s degree in Statistics/Biostatistics or related field.
• 6+ years of statistical programming in pharma/biotech/CRO.
• Advanced SAS and R with Git version control.
• Extensive SDTM/ADaM and TLF experience.
• Knowledge of CDISC standards and regulatory submissions.
• Strong communication and collaboration across teams.

Responsibilities

• Lead statistical programming activities and provide hands‑on SAS/R analyses.
• Bridge Biostatistics and CDM; help develop CRFs and programming standards.
• Lead CROs/contractors; ensure deliverables, timelines and budgets.
• Develop tools (R packages, macros, dashboards) to enhance team efficiency.
• Lead NDA eSubmission package preparation and define.xml generation.

Skills

SAS programming

R programming

Git versioning

SDTM

ADaM

TLF

Regulatory submissions

Education

Masters in Stats

Tools

Pinnacle 21

Python

Job description

Kardigan in South San Francisco, CA or Princeton, NJ, is seeking a Senior Manager of Statistical Programming to lead programming activities, perform hands-on analyses using SAS and R, and review deliverables for in-house and outsourced work. The role bridges Biostatistics and CDM, helps develop CRFs and standards, and leads NDA eSubmission and define.xml generation while mentoring a cross-functional team and collaborating with CROs.