Programming Manager, Sr.
About the Role
The Senior Programming Manager is responsible for leading statistical programming activities across complex clinical trials and regulatory submissions. This senior leadership role provides strategic oversight for programming deliverables, drives consistency across studies, contributes to enterprise programming standards, and supports organizational capability development.
Key Responsibilities
Lead statistical programming activities for complex clinical trials or multiple studies.
Oversee programming deliverables throughout the clinical development lifecycle.
Ensure high-quality, timely, and compliant programming outputs.
Provide technical leadership for programming teams and cross-functional partners.
Lead programming activities supporting regulatory submissions.
Ensure compliance with FDA, EMA, and global regulatory standards.
Oversee submission-ready datasets, tables, listings, and figures (TLFs).
Support submission quality reviews and regulatory inspections.
Serve as a Subject Matter Expert (SME) for CDISC SDTM and ADaM standards.
Drive consistency across clinical programming deliverables.
Contribute to enterprise programming standards and governance initiatives.
Lead initiatives that improve programming efficiency and quality.
Support implementation of new programming systems and technologies.
Drive automation, standardization, and best programming practices.
Participate in capability-building initiatives across the organization.
Mentor programmers and support knowledge sharing across teams.
Collaborate with Biostatistics, Data Management, Clinical Operations, and Regulatory Affairs.
Provide technical guidance and programming expertise.
Participate in governance committees and strategic initiatives.
Develop programming standards and training materials.
Support onboarding and technical development of programming staff.
Promote continuous improvement and professional development.
Contribute to enterprise learning initiatives.
Required Qualifications
Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Life Sciences, or a related field.
Minimum 8 years of statistical programming experience within the pharmaceutical or biotechnology industry.
Extensive experience with SAS programming.
Strong knowledge of CDISC SDTM and ADaM standards.
Experience supporting clinical trial programming and regulatory submissions.
Strong understanding of clinical data structures and regulatory requirements.
Excellent analytical, organizational, and problem-solving skills.
Able to manage multiple complex projects simultaneously.
Strong verbal and written communication skills.
Proven ability to work effectively within cross-functional global teams.
Preferred Qualifications
Oncology clinical trial experience.
Regulatory submission experience (FDA, EMA, PMDA, or other health authorities).
Experience leading enterprise programming standards initiatives.
Knowledge of programming process automation and system innovation.
Previous experience serving as a programming subject matter expert or capability lead.
Required Skills
SAS Programming
Statistical Programming
Clinical Trial Programming
CDISC SDTM
CDISC ADaM
Clinical Data Management
Regulatory Submissions
FDA Submission Standards
Clinical Data Analysis
Tables, Listings & Figures (TLFs)
Oncology Clinical Trials
Biostatistics
Clinical Research
Pharmaceutical Programming
Biotechnology
Data Validation
Programming Standards
Process Improvement
Quality Assurance
Technical Leadership
Cross-functional Collaboration
Project Management
Problem Solving
Analytical Thinking
Communication Skills
Training & Mentoring
Governance & Compliance
Compensation & Benefits
Salary Range (U.S.): $128,080 – $192,120 annually
Eligibility for discretionary bonuses and long-term incentive programs
Benefits Include:
401(k) with 100% company match on the first 6% of contributions
Medical, dental, and vision insurance
Health Savings Account (HSA)
Critical illness, accident, and hospital indemnity insurance
Paid vacation, sick leave, and company holidays
12 weeks of paid parental leave
Tuition reimbursement
Lifestyle Spending Account
Commuter benefits
Backup child and adult care programs
Financial wellness resources
Employee well-being and mental health support
Work Environment
Remote work opportunity with collaboration across global teams.
Agile, science-driven work environment.
Collaboration with Clinical Development, Biostatistics, Regulatory Affairs, and Data Management.
Opportunities to contribute to global clinical development programs and enterprise initiatives.
Equal Opportunity Employer
Genmab is committed to fostering a diverse, inclusive, and equitable workplace where innovation thrives through collaboration and respect. Employment decisions are made based on qualifications, skills, and business needs without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.