Sr. Statistical Programmer
Immunocore

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.

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 Responsibilities
The role of the Sr. Statistical Programmer is to oversee and/or contribute to the delivery of the in-house deliverables including CDISC conversion; statistical programming contributions provided by Contract Research Organizations for clinical trials; to provide planned, ad hoc and exploratory statistical programming services including quality control; and to help create departmental systems, standards, and processes. This position is located onsite at our Rockville, MD office.

In close collaboration with Lead Study Biostatisticians, supporting statisticians, and clinicians; the Sr. Statistical Programmer will ensure that technical components that support the analysis, reporting, decision-making, publications, and regulatory submissions are delivered to a consistently high quality.

KEY RESPONSIBILITIES
* Create or perform a review and approval of technical specification documents
o e.g. CDISC specifications, Tables, Figures and Listings (TFL) mock shells
* Create or perform a review and approval of externally delivered programming outputs, with a focus on quality
o e.g. SDTM/ADaM datasets, TFL outputs
* Serve as a designated member of study team in the role of lead Statistical Programmer for clinical trial(s)
* Perform ad-hoc programming to support internal decision making
o Delivery of SDTM, ADaM datsets, Tables, Figures and Listings
* Production and quality control of datasets and output to support:
o Clinical study reports (CSRs)
o Development Safety Update Reports (DSURs)
o Periodic Benefit-Risk Evaluation Reports (PBRERs)
o Investigator Brochures (IBs), etc.
* Production of datasets and output to support PK/PD analyses
* Undertake submission planning activities, for example:
o Data pooling strategy
o Programming input to High Level Documents
o Response to regulatory questions
* Develop quality standards to drive efficiency and reuse of metadata
* Develop a comprehensive validation process for in house programming deliverables

Experience & knowledge
* Mathematical, Statistical, Computer Science or Life Science degree with 5+ years of relevant experience.
Industry knowledge
o Drug development lifecycle
o CDISC standards
o Extensive knowledge of Health Authority requirements
* SAS® programming skills
o Base
o Macro
o SQL
o SAS Graph
* Experience a as lead programmer
* Excellent written and verbal communication skills
* A proven ability to solve problems, working independently of others
* Experience of alternative programming languages, e.g. R, is desirable, but not essential

Education: A 4-year college degree from an accredited university. A degree or graduate in Statistics, Biostatistics, Computer Science, or related field is a plus.
Qualifications: Proficiency in SAS programming. SAS Certifications desirable