Senior/Principal Statistical Programmer (m/w)

Division Global Drug Development
Geschäftseinheit GDO GDD
Standort Oberhaching (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 238865BR


Stellenbeschreibung

• Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development.
• Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).
• Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.
• Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.
• Provide and implement statistical programming solutions; ensure knowledge sharing.
• In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
• Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
• As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.



Research & Development


Mindestanforderungen

• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
• Ideally 5+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
• Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables
• Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
• Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures)
• Good communications and negotiation skills, ability to work well with others globally
• Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project
• Fluent English (oral and written)



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