Job Details: Senior Manager, Statistical Programming Vacancy Name: Senior Manager, Statistical Programming
Vacancy No: VN517
Employment Type: Full Time
Location of Role: Gaithersburg, MD
Conshohocken, PA
Oxford, UK
Department: Biometrics
Key Responsibilities: The role of the Senior Manager, Statistical Programming is to oversee the timely delivery of the statistical programming outputs either generated in-house or provided by Contract Research Organizations for clinical trials; to oversee, manage, and provide in-house statistical programming analysis services; and to help create departmental systems, standards, and processes.
In close collaboration with the Head of Statistical Programming and supporting statisticians and clinicians, the Senior Manager, 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. This onsite position can be located in the US at either the Gaithersburg, MD or Conshohocken, PA locations, or at our Oxford, UK site.
Oversee, develop, manage, and/or review deliverables including: Technical specification documents (e.g. CDISC specifications for SDTM and ADaM datasets, Reviewers Guide, Define.xml) Programming outputs (e.g. SDTM/ADaM datasets, Tables, Figures and Listings (TFLs)) Validation of Programming Deliverables Planned TFLs for Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), PBRERs, Manuscripts, Investigator Brochures (IBs), etc. Exploratory analyses for posters, publications, conferences, regulatory responses, and internal decision making. Data validation and consistency checks and data listings Mentor or manage junior statistical programmers. Develop processes and tools to drive efficiency and quality. Develop global macros as needed. Lead programming support within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables in assigned projects and areas. Work with statisticians and study team members to determine needs and priorities. Education, Experience and Knowledge: Essential Qualifications: Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 10+ years of programming experience or master's degree with 8+ years of programming experience. Demonstrated proficiency in SAS programming skills including: Base Macro SQL SAS Graph Industry knowledge: Drug development lifecycle CDISC standards Extensive knowledge of Health Authority requirements Ability to effectively represent the Statistical Programming in cross-functional teams. A proven ability to solve problems, ability to work both independently and collaboratively within a team. Excellent written and verbal communication skills. Experience of alternative programming languages e.g. R, Python, XML, WinBUGs, etc. is desirable, but not essential. 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 recognized 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.
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