2/2 Principal Statistical Programmer

Found in: beBee S IE - 3 weeks ago

Ireland Novartis Farmacéutica Full time

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as [Role] #GCO

The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverables in Novartis Global Drug Development.

Your responsibilities include, but are not limited to:

• 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.
• 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. Provide and implement statistical programming solutions; ensure knowledge sharing.
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

What you’ll bring to the role:

Required Experience & Qualifications:

• Fluent English (oral and written).
• Ideally 5+years of work experience in a programming role
• 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).
• Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project
• Good communications and negotiation skills, ability to work well with others globally

Desirable Experience & Qualifications:

• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field #J-18808-Ljbffr

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