Associate Director, Statistical Programming

Celldex Therapeutics; 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

Overview

This role at Celldex Therapeutics is a senior-level leadership position focused on overseeing the end-to-end statistical programming lifecycle. It combines technical oversight, project management, and cross-functional collaboration to ensure clinical trial data meets rigorous regulatory standards.

Responsibilities

• Lead or Co-ordinate statistical programming activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.
• Comply with company, department and industry standards (e.g. CDISC) and processes, responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Oversee the creation of CDISC compliant submission readiness output including but not limited to datasets (SDTM, ADaM), Tables, Listings and Figures (TFLs) and associated Define packages.
• Oversee the external programming activities outsourced to CROs to ensure the quality including standard programming practice, validation, and documentation.
• Build and maintain effective working relationships with cross-functional teams both internally and externally, contribute to the status of deliverables and critical programming aspects (timelines, scope, resource plan etc.)
• Support all in-house programming activities, if needed, including but not limited to regulatory filings, adhoc analysis, publication requests etc.

Qualifications

• MS in Statistics or related field
• 8+ years of SAS programming experience in the biotech/pharma industry
• Experience as the lead programmer coordinating programming teams to support multiple regulatory submissions
• Experience managing people and projects.
• Proficiency with SAS Base, Macro, SQL, and Graph; working knowledge of R is a plus.
• Experience working with and managing external CROs or FSPs for programming deliverables.
• Familiarity with CDISC (SDTM/ADaM) standards and ability to adapt them for non-interventional data structures.
• Excellent communication skills and ability to work cross-functionally in a lean team environment.

Compensation Statement

The expected base salary for this position is: $153616.00 to $199501.00.

Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days.

• base salary
• annual discretionary bonus
• long term incentive
• 401(K) plan with employer contribution
• health care and other insurance benefits (for employee and family)
• paid holidays
• vacation
• sick days

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.