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Warren Township, New Jersey, United States · Hybrid
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Lead statistical programming activities for complex clinical projects and drive innovation through the adoption of R packages and AI-enabled tools. Coordinate internal and external resources while ensuring the quality and audit readiness of all statistical analysis deliverables.
Requires a university degree in life sciences, computer science, statistics, or a related field with proven leadership experience in drug development. Candidates must possess a deep understanding of clinical trial methodology, GCP, and the ability to manage simultaneous trials in a global environment.
Lead statistical programming activities as a Lead/Program Programmer for a large-sized or complex project or group of projects globally or locally, or disease area with phase I to IV clinical studies in Novartis Global Drug Development.
Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at project or disease level. Develop statistical programming strategy and scientific documentation for the project(s) or disease area together with the Biostatistician(s). Accountable for the assignment of resources and workload within his/her TA community and ensures sharing of resources between groups in order to meet company objectives and priorities.
May act as functional manager of local/global associates including providing supervision and advice to these programmers on functional expertise and processes.
Build and maintain effective working relationships with cross-functional teams including Biostatistics and Data Management counterparts, able to summarize and discuss status of deliverables and critical programming aspects, such as,timelines, scope, and resource planning. SP representative at project level and in the Submission team, or in local leadership team.
Develop programming strategy 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. Partner with the functional mentors to support capability development, appropriate tool adoption, and alignment with standards and business needs.
Accountable for timely and quality development and validation of all statistical programming components on assigned project(s). Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
Provide authoritative technical and professional recommendations as representative of the statistical programming function at project level or for a major non-clinical initiative.
University or college degree in life science, computer science, data science, pharmacy, statistics, nursing or equivalent relevant degree.
Proven leadership, collaboration and organizational skills with demonstrated ability to successfully manage simultaneous trials and meet deadlines
Excellent understanding of clinical trials methodology, GCP and medical terminology
Must be able to anticipate challenges and risks and proactively suggest/implement solutions
Ability to work under pressure demonstrating agility through effective and innovative team leadership
Excellent interpersonal skills and proven ability to operate effectively in a global environment. Foster a team environment that values learning, adaptability, and continuous improvement. Ability to influence and communicate across functions and to external stakeholders
Experience in Drug Development with experience in Statistical Programming
Management or leadership experience
Novartis Compensation Summary:
The salary for this position is expected to range between $145,600 and $270,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a
variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/3Nboxki
Offices: Novartis Campus, Basel, Baselstadt 4002, CH · One Health Plaza, East Hanover, NJ 07936, US · Calle 93B S-31, Bogota, Bogota, D.C. 110541, CO · Merrion Road, Dublin, County Dublin, IE · Na Pankraci 1724/129, Prague, Prague 140 00, CZ
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