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- Tasks: Lead statistical programming for pivotal studies and mentor fellow programmers.
- Company: Join Novartis, a leader in reimagining medicine to improve lives.
- Benefits: Enjoy remote work options and a supportive, inclusive culture.
- Why this job: Make a real impact on patients' lives while collaborating with passionate professionals.
- Qualifications: BA/BS/MS in relevant fields with 5+ years in statistical programming.
- Other info: Be part of a diverse team committed to innovation and community.
The predicted salary is between 36000 - 60000 £ per year.
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Summary
Responsible for all statistical programming/data review reporting and analytics development 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.
Summary
Responsible for all statistical programming/data review reporting and analytics development 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
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.
To do this, we are optimizing and strengthening our processes and ways of working.
We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together!
The Role
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.
This role offers home based contract
Key Accountabilities
- 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.
Your Experience
- 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
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.
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
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Seniority level
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Seniority level
Mid-Senior level
Employment type
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Employment type
Full-time
Job function
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Job function
Research, Analyst, and Information Technology
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Industries
Pharmaceutical Manufacturing
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Principal Statistical Programmer employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Statistical Programmer
✨Tip Number 1
Familiarise yourself with the latest industry standards, particularly CDISC data structures and regulatory requirements. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality in statistical programming.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in statistical programming. Attend relevant conferences or webinars to connect with potential colleagues at Novartis and gain insights into their work culture and expectations.
✨Tip Number 3
Showcase your experience with SAS and any advanced programming techniques you've mastered. Be prepared to discuss specific projects where you led programming activities or collaborated with cross-functional teams, as this aligns closely with the role's responsibilities.
✨Tip Number 4
Research Novartis' recent projects and initiatives in drug development. Understanding their current focus areas can help you tailor your discussions during interviews and show that you're genuinely interested in contributing to their mission.
We think you need these skills to ace Principal Statistical Programmer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in statistical programming, particularly in clinical trials. Emphasise your proficiency in SAS and any experience with CDISC standards, as these are crucial for the role.
Craft a Strong Cover Letter: In your cover letter, express your passion for improving patient outcomes through statistical programming. Mention specific projects or experiences that demonstrate your ability to lead programming activities and collaborate effectively with cross-functional teams.
Showcase Your Technical Skills: Clearly outline your technical skills related to statistical programming, including your experience with SAS and any other relevant software. Provide examples of how you've used these skills in past roles to deliver high-quality results.
Highlight Collaboration Experience: Since the role involves working closely with biostatistics and other teams, include examples of successful collaborations in your application. Discuss how you’ve mentored others or coordinated efforts on projects to achieve common goals.
How to prepare for a job interview at Novartis
✨Showcase Your Technical Skills
As a Principal Statistical Programmer, you'll need to demonstrate your advanced SAS skills. Be prepared to discuss specific projects where you've used SAS to develop and validate deliverables, and how you ensured compliance with industry standards like CDISC.
✨Emphasise Collaboration Experience
This role requires strong collaboration with cross-functional teams. Share examples of how you've successfully worked with biostatisticians or other programmers, highlighting your ability to coordinate activities and mentor others in programming best practices.
✨Discuss Regulatory Knowledge
Familiarity with regulatory requirements is crucial. Be ready to talk about your understanding of GCP and how you've applied this knowledge in previous roles, especially in relation to statistical programming and data review.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills. Think of situations where you had to make programming decisions under tight deadlines or resolve conflicts within a team, and be ready to explain your thought process and outcomes.
