Project Lead

Jobtailor; Massachusetts; On-site; USD 140,000 - 190,000; Full time

Job summary

Jobtailor seeks a senior statistical programmer to lead and hands-on deliver high-quality programming outputs for global studies, ensuring regulatory compliance and standardization across analyses.

The role requires 7+ years of SAS or R programming, CDISC SDTM/ADaM expertise, and experience coordinating with vendors and cross-functional teams. Fluency in English is essential, with additional languages a plus.

Qualifications

• Bachelor's degree required in a quantitative or health science field.
• 7+ years hands-on SAS or R programming experience.
• Proficiency with CDISC standards (SDTM/ADaM) and regulatory submission requirements.
• Experience coordinating and delivering study/programming assets in a global setting.
• Experience managing third party vendors and outsourcing relationships.
• Experience driving automation and digital transformation initiatives.
• Fluent in English; additional languages a plus.

Responsibilities

• Provide leadership and hands-on support for programming deliverables to ensure quality and regulatory compliance.
• Plan and track programming activities, timelines and resources globally.
• Maintain standardization and consistency of specifications across studies and analyses.
• Lead regulatory submission activities, ensuring CDISC data packages meet health authority expectations.
• Oversee outsourcing engagements and coordinate with external vendors.
• Collaborate with project statisticians and cross-functional teams in meetings.
• Support process improvements and outsourcing operation management.
• Mentor junior staff in programming techniques and standards.

Skills

SAS Programming

R Programming

CDISC Standards

Regulatory Submissions

Project Management

Education

Bachelor's degree in Statistics, Mathematics, Computer Science or related health sciences field

Job description

• Lead scientific programming deliverables - Provide leadership, guidance and hands‑on support to ensure high-quality, timely programming outputs while ensuring compliance with internal standards, SOPs and regulatory requirements
• Manage project planning & resources - Plan and track programming activities, timelines, and resource utilization in a global setting
• Ensure standardization & consistency - Maintain consistency in specifications and programming deliverables across individual studies and integrated analyses
• Drive regulatory submissions - Lead regulatory submission activities, including electronic submission packages, ensuring CDISC data packages comply with Health Authority expectations (FDA, PMDA, CDE, KFDA, etc.)
• Oversight activities for outsourcing engagements and guide team interactions with external resources
• Collaborate cross-functionally - Partner effectively with project statistician(s); participate in clinical project meetings and contribute relevant inputs
• Act into transversal responsibility, contributing to process improvement or ensuring outsourcing operation management
• Mentor - Provide guidance to junior staff on programming techniques and standards implementation

Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science or related health sciences field
• 7+ years of hands‑on experience in SAS or R programming
• proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements
• Proven success performing, coordinating and overseeing the preparation, execution, reporting and documentation of all study and project‑level asset development programming deliverables in a global setting
• Proven experience in dealing with third party vendors
• Demonstrated experience implementing automation and digital transformation initiatives
• Fluent in English; additional languages a plus.

Core Competencies

Demonstrates expertise in SAS or R programming, with a strong focus on CDISC standards and regulatory submissions. Proven ability to lead programming deliverables, manage resources, and mentor junior staff while ensuring compliance and process improvement.

Highest‑signal resume keywords

• SAS Programming
• R Programming
• CDISC Standards
• Regulatory Submissions
• Project Management

ATS Optimization Keywords

Hard Skills

• Statistical Analysis
• Data Management
• Programming Techniques
• Automation Implementation
• Digital Transformation

Soft Skills

• Leadership
• Collaboration
• Mentoring
• Communication

Industry Keywords

• Health Authority Compliance
• FDA
• PMDA
• CDE
• KFDA
• Outsourcing Management
• Global Project Coordination