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For Companies At a Glance
- Tasks: Lead statistical programming for clinical studies, ensuring high-quality deliverables.
- Company: Join Novartis, a leader in reimagining medicine to improve lives.
- Benefits: Enjoy a full-time role with opportunities for personal and professional growth.
- Why this job: Be part of a passionate team making a real impact on patients' lives.
- Qualifications: 7+ years in programming, ideally in clinical trials; expert SAS skills required.
- Other info: Diversity and inclusion are at the heart of our culture.
The predicted salary is between 48000 - 84000 £ per year.
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.
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 Senior Principal Programmer is responsible for all statistical programming aspects of several studies, a medium to large sized project or project-level activities (incl. submission and post-marketing activities). The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables.
Key Accountabilities
- Lead statistical programming activities as Trial Programmer for several studies or as Lead/ Program Programmer 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.
- 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 project-level team.
- Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production.
- 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. CSPD and other project-level strategies).
- Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects.
- 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.
- 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
- Act as subject matter expert (SME) or, as assigned, lead 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
- Work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
- Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs
- 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)
- Proven communications and negotiation skills, ability to work well with others globally and influence
- 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
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.
Benefits and Rewards
Learn about all the ways we’ll help you thrive personally and professionally.
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Senior Principal Statistical Programmer employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Principal Statistical Programmer
✨Tip Number 1
Familiarise yourself with Novartis' drug development processes and their commitment to quality. Understanding their approach will help you align your experience with their expectations during discussions.
✨Tip Number 2
Network with current or former employees of Novartis, especially those in statistical programming roles. They can provide valuable insights into the company culture and what they look for in candidates.
✨Tip Number 3
Stay updated on the latest industry standards and regulatory requirements relevant to statistical programming, such as CDISC. This knowledge will demonstrate your commitment to compliance and excellence in your field.
✨Tip Number 4
Prepare to discuss specific examples of your past projects where you led programming activities or collaborated with cross-functional teams. Highlighting your leadership and teamwork skills will be crucial in showcasing your fit for the role.
We think you need these skills to ace Senior Principal Statistical Programmer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in statistical programming, particularly with SAS. Emphasise your expertise in clinical trials and any leadership roles you've held in programming projects.
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 align with Novartis' mission and values.
Showcase Technical Skills: Clearly outline your technical skills related to statistical programming, including your proficiency in SAS and knowledge of industry standards like CDISC. Provide examples of how you've applied these skills in previous roles.
Highlight Collaboration Experience: Since the role involves working with cross-functional teams, include examples of successful collaborations in your application. Discuss how you’ve influenced project outcomes through teamwork and communication.
How to prepare for a job interview at Novartis
✨Showcase Your Technical Expertise
As a Senior Principal Statistical Programmer, it's crucial to demonstrate your advanced knowledge of programming software like SAS. Be prepared to discuss specific projects where you've successfully developed and validated deliverables, and highlight your experience with advanced MACROs.
✨Understand Regulatory Standards
Familiarise yourself with industry standards such as CDISC and regulatory requirements relevant to statistical programming. During the interview, be ready to explain how you ensure compliance with these standards in your work, as this will show your commitment to quality and accuracy.
✨Emphasise Collaboration Skills
This role requires effective collaboration with cross-functional teams. Share examples of how you've successfully worked with biostatistics or other departments to achieve project goals. Highlight your communication and negotiation skills, as these are key to building strong working relationships.
✨Prepare for Problem-Solving Scenarios
Expect to encounter questions that assess your problem-solving abilities. Think of specific challenges you've faced in previous roles and how you approached them. Being able to articulate your thought process and the outcomes will demonstrate your expertise and strategic thinking.