Director, Statistical Programming

Immunocore; Gaithersburg (MD); On-site; USD 180,000 - 250,000; Full time

Job summary

Immunocore in Gaithersburg/Radnor seeks a Director, Statistical Programming to lead the Statistical Programming function, set strategy, and ensure timely, high‑quality analyses to support regulatory submissions. You will oversee in‑house deliverables (CDISC SDTM/ADaM data, TFLs for CSRs/DSURs/IBs), manage budgets and vendors, and mentor a team of programmers while promoting continuous learning.

The role requires strong SAS expertise, CDISC standards, and leadership with a track record of

Qualifications

• Bachelor’s or Master’s degree in a technical discipline such as Mathematics, Statistics, CS or Life Sciences.
• 10+ years’ experience in pharma/biotech/CRO.
• Advanced SAS programming including SAS/BASE, SAS/Macro, SAS/SQL and plotting.
• Strong CDISC SDTM/ADaM knowledge and define.xml.
• Excellent written and verbal communication and leadership experience.

Responsibilities

• Establish and maintain processes, tools, and standards for all programmed deliverables.
• Manage budgets, resources, and resourcing strategies.
• Oversee internal statistical programming activities including CSRs, DSURs, and IBs.
• Develop and implement AI strategy in programming.
• Mentor direct reports and contractors.
• Collaborate with statisticians and study teams to determine project needs.
• Address escalated performance issues and ensure quality.

Skills

Leadership

People management

Cross-functional collaboration

Strategic planning

Education

Bachelor’s or Master’s degree in Mathematics/Statistics/CS/Life Sciences

Tools

SAS (BASE, Macro, SQL)

CDISC SDTM/ADaM

Job description

Location of role Gaithersburg, MD, Radnor, PA

Department Biometrics

Key Responsibilities The role of the Director, Statistical Programming is to lead the Statistical Programming function, which will establish programming strategy, involve determining resource needs, establishing and maintaining processes and standards, overseeing the performance of Contract Research Organizations and other vendors, and managing direct reports. The scope of in-house deliverables for the department will include CDISC (SDTM and ADaM) data sets; tables, figures, and listings (TFLs) for clinical study reports (CSRs), development safety update reports (DSURs), investigator brochures, etc.; exploratory analyses and outputs for publications and internal data exploration; and listings and other deliverables to assist with data cleaning and review.

In close collaboration with the Head of Biometrics and supporting statisticians and clinicians, the Director, Statistical Programming will ensure that statistical analyses that support decision-making, publications, study reports, and regulatory submissions are delivered expeditiously and at a consistently high quality.

The individual will demonstrate expert skills, promoting a culture of psychological safety and encouraging experimentation. They will ensure positive engagement and motivation, manage succession planning, support career progression, and promote talent retention. The individual will champion continuous learning, use advanced coaching techniques, and create a positive work environment that motivates the team to achieve stretch goals and tackle challenging business situations. They will manage escalated performance issues through appropriate mediation and intervention.

Key Responsibilities:

• Establish and maintain processes, tools, and standards relating to the production of all programmed deliverables (e.g., CDISC-compliant data sets and TFLs and data packages for regulatory submissions)
• Manage budgets, resource needs, and resourcing strategies for the function
• Oversee, manage, and/or perform internal statistical programming activities including:
• Planned TFLs for Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), Investigator Brochures (IBs), etc.
• Exploratory analyses for publications, regulatory responses, and internal decision making
• Data validation and consistency checks and data listings
• Develop and implement AI strategy in programming
• Manage and mentor statistical programming direct reports and contractors
• Develop processes and tools to drive efficiency and quality
• Work with statisticians and study team members to determine project needs and priorities
• Other responsibilities as assigned

Supervisory Responsibility:

• Recruit, mentor, and manage a team of statistical programmers/managers, including setting goals, reviewing performance, and career development.

Education, Experience and Knowledge:

Essential Qualifications:

• Bachelor’s or Master's degree or equivalent in a technical discipline such as Mathematics, Statistics, Computer Science or Life Sciences
• At least 10 years’ experience working in the pharmaceutical, biotech, or CRO industry
• Advanced SAS® programming skills including SAS/BASE, SAS/Macro, SAS/SQL and plotting procedures
• Advanced knowledge and understanding of CDISC (SDTM, ADaM, define.xml) standards and implementations
• Excellent written and verbal communication skills
• Experience managing people
• A proven ability to solve problems working both independently and in teams.

Preferred Qualifications:

• Experience with alternative programming and mark-up languages (e.g., R, Python, XML) is desirable, but not essential

Other:

• Willingness to travel domestically or internationally as required by projects