About the CompanyImmunocore (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.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesThe role of the Director, Statistical Programming is to lead the Statistical Programming function, which will 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.
• 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:
o Planned TFLs for Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), Investigator Brochures (IBs), etc.
o Exploratory analyses for publications, regulatory responses, and internal decision making
o Data validation and consistency checks and data listings
• 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
Skills & Experience:
• 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
• Experience with alternative programming and mark-up languages (e.g., R, Python, XML) is desirable, but not essential
Willingness to travel domestically or internationally as required by projects.
Annual salary range for US:
This position is eligible for standard Company benefits, including medical, dental, vision, time off and 401k, as well as participating in Immunocore's annual incentive plans. Incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level.
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