Director, Statistical Programming

Immunocore; Radnor (Delaware County); Sur place; USD 190 000 - 210 000; Plein temps

Résumé du poste

Immunocore is seeking a Director of Statistical Programming to lead the Statistical Programming function, set programming strategy, and manage external vendors and internal staff. The role oversees CDISC data, TFLs for CSRs/DSURs/IBs, and analyses for publications and regulatory submissions.

You will partner with Biometrics leadership to deliver high-quality analyses on tight timelines, drive continuous learning, and mentor staff while promoting a culture of psychological safety and performance

Qualifications

• Bachelor’s or Master’s degree in a technical discipline such as Mathematics, Statistics, Computer Science or Life Sciences.
• At least 10 years’ experience 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.

Responsabilités

• 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 CSRs, DSURs, 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

Connaissances

SAS programming

CDISC SDTM/ADaM

Team leadership

Communication skills

Problem solving

Formation

Bachelor’s or Master’s degree in Mathematics, Statistics, Computer Science or Life Sciences

Outils

SAS/BASE

SAS/Macro

SAS/SQL

Description du poste

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.

• 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

US Salary Range

$190,000 to $210,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.