Employment Type
Full Time
Location of role
Gaithersburg, MD, Radnor, PA
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.
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 datasets, 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 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
ESSENTIAL COMPETENCIES
1. Communication Proficiency
2. Must work with professional discretion and confidentiality
3. High Prioritization
4. Self-motivated- able to work autonomously
5. Able to anticipate challenges and devise strategies for success
6. Result and deadline orientated
7. Time Management
8. Collaboration Skills, and ability to work as part of a diverse team
9. Excellent presentation skills
10. Personal Effectiveness/Credibility
11. Flexibility
Education & qualifications
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
US Salary Range
$93,000-$155,000
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.
