Key responsibilities:
- Lead SP activities as Trial Programmer for one or multiple trial(s) or as a Lead/ Program Programmer for a program or an indication.
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May coordinate activities of internal/ external programmers. Make SP decisions and propose strategies at study, program or indication/ disease level.
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May act as functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes.
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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 SP representative in study- or program-level team.
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Review eCRF, data structures, and ensure program-level standardization for effective pooling and efficient case record tabulation (CRT) production.
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Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. program-level strategies).
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Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects.
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Ensure timely and quality development and validation of datasets and outputs for clinical study reports (CSRs), regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/program. Understand Git-based version control workflows and their role in supporting collaborative, traceable, and reproducible programming activities.
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Responsible for quality control and inspection readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Establishes robust expectations and frameworks for reproducibility, documentation, and code quality across complex workflows; leads refinement of templates, standards, and governance.
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Maintain up-to-date advanced knowledge of statistical programming languages (e.g. R, SAS, ) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), act as an expert for advanced analysis, reporting, automation and enterprise-scale workflow optimization, and drive adoption of reusable solutions and modern approaches across studies or programs
Essential Requirements:
- BS/MS degree in statistics, computer science, mathematics, data science, life science or equivalent relevant degree
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Extensive experience and deep expertise in Statistical programming languages (e.g., R, SAS, or Python) to drive standardization across studies or programs and effectively adopt R packages (e.g. Tidyverse), R Shiny Applications, AI-enabled tools etc. to support data visualization, version control (e.g. Git-based), and reproducible workflows.
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Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications
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Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs
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Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures)
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Proven communications and negotiation skills, ability to work well with others globally and influence
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Experience as Trial/Lead/Program Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/program, ability to transfer own knowledge to others
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: £49,140.00 - £91,260.00 Annual
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
