Head of Statistical Programming & Data Strategy

Kardigan, Inc.

South San Francisco, Northern (CA, KY)

Hybrid

USD 180,000 - 230,000

Full time

9 days ago

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Job summary

Kardigan, Inc. is seeking a Senior Manager of Statistical Programming in South San Francisco, CA or Princeton, NJ on-site four days a week. You will lead statistical programming activities, implement analyses with SAS/R, review deliverables, and help modernize reporting with open-source tools.

A bridge between Biostatistics and CDM, you will influence CSP and regulatory submissions. The role requires strong leadership, SDTM/ADaM expertise, and collaboration with cross-functional teams to deliver

Qualifications

Master's degree in Statistics/Biostatistics/Mathematics/CS or related field.
At least 6 years' statistical programming experience in pharma/biotech/CRO.
Advanced SAS and R programming with SDTM/ADaM and TLF.
Experience with Git for version control.
Knowledge of CDISC SDTM/ADaM standards.

Responsibilities

Lead Statistical Programming activities for studies from planning to delivery.
Review SAP, Data Presentation Plan, and Table Shells for clarity and completeness.
Produce/validate SDTM, ADaM, and TLF for CSR, regulatory submissions, and analyses.
Manage CROs and contractors, ensuring quality and timelines.
Collaborate with Biostatistics and CDM to develop specifications and reviews.
Develop company tools (R packages, dashboards) to enhance efficiency.
Create define.xml and lead NDA eSubmission package preparation.