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Senior Principal Statistical Programmer
4 weeks ago
The Senior Principal Statistical Programmer will be responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high-quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines.
About the Role
Key requirements
- Lead statistical programming activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
- Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level.
- May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes.
- Collaborate with cross-functional teams, discuss status of deliverables and critical programming aspects (timelines, scope, resource plan)
- Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production.
- Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project.
- Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
- Act as subject matter expert or as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.
This role will be hybrid, requiring 3 days per week in our Dublin office.
Your Experience
- Fluency in English with strong negotiation skills, ability to work well with others globally and influence. BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
- Must have strong programming skills in R/R Shiny. Python is desirable (and SAS optional). Demonstrated knowledge of data visualization , exploratory analysis.
- Exposure to late phase studies & Real-World Evidence. (for strong candidates we can offer training)
- Ideally 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry. Experience in Health Technology Assessment /HEOR is preferable
- Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
- Advanced 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/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/project, ability to transfer own knowledge to others
- Please note that for this role we are unable to provide visa sponsorship.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion :
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
IE02 (FCRS = IE002) Novartis Ireland Ltd
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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