Senior Director of Statistical Programming & Submissions

Celldex Therapeutics, Inc.; Needham (MA); On-site; USD 154,000 - 200,000; Full time

Job summary

Celldex Therapeutics, Inc. seeks a senior leader to oversee the end-to-end statistical programming lifecycle, blending technical oversight with project management to meet rigorous regulatory standards.

The role leads programming activities, ensures CDISC compliance for submissions, and manages external CROs while mentoring staff and coordinating with cross-functional teams to deliver timely analyses and outputs.

Qualifications

• MS in Statistics or related field is required.
• 8+ years of SAS programming experience in biotech/pharma.
• Experience leading programming teams for regulatory submissions.
• Experience managing people and projects.
• Proficiency with SAS Base, Macro, SQL, and Graph; working knowledge of R.
• Experience with external CROs or FSPs for programming deliverables.
• Familiarity with CDISC (SDTM/ADaM) standards.

Responsibilities

• Lead or coordinate statistical programming activities across study teams.
• Ensure quality control and audit readiness of programming deliverables.
• Oversee CDISC submission outputs (SDTM, ADaM, TFLs, Define).
• Manage external CROs/FSPs for programming deliverables.
• Foster cross-functional collaboration and timely deliverables.
• Support regulatory filings and ad-hoc analyses when needed.

Skills

Lead programmer coordination

Project management

Mentoring

Cross-functional collaboration

Communication

Education

MS in Statistics or related field

Tools

SAS Base

SAS Macro

SQL

SAS Graph

R

Job description

Celldex Therapeutics, Inc. seeks a senior leader to oversee the end-to-end statistical programming lifecycle, blending technical oversight with project management to meet rigorous regulatory standards.

The role leads programming activities, ensures CDISC compliance for submissions, and manages external CROs while mentoring staff and coordinating with cross-functional teams to deliver timely analyses and outputs.