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For Companies At a Glance
- Tasks: Lead statistical programming for pivotal studies and ensure high-quality deliverables.
- Company: Join Novartis, a leader in innovative medicine dedicated to improving lives.
- Benefits: Enjoy a home-based contract with opportunities for professional growth and development.
- Why this job: Be part of a passionate team making a real impact on patients' lives.
- Qualifications: BA/BS/MS in relevant fields with 5+ years in clinical trials and advanced SAS skills.
- Other info: Commitment to diversity and inclusion; join our talent community for future opportunities.
The predicted salary is between 43200 - 72000 £ per year.
Job Description 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.
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.
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.
- Coordinate 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
- 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
Skills Desired
Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis
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Principal Statistical Programmer employer: Healthcare Businesswomen’s Association
Contact Detail:
Healthcare Businesswomen’s Association 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 enhance your understanding but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in statistical programming. Engaging with them can provide insights into the role and may even lead to referrals or recommendations for positions at StudySmarter.
✨Tip Number 3
Showcase your advanced SAS skills by discussing specific projects where you developed and validated deliverables. Be prepared to explain your approach to problem-solving and how you ensured quality control in your work.
✨Tip Number 4
Highlight your experience in leading teams or coordinating with internal and external programmers. Emphasising your leadership skills and ability to mentor others will set you apart as a candidate who can contribute to a collaborative environment.
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 with SAS and clinical trials. Emphasise any leadership roles or mentoring experiences you've had, as these are key for the Principal Statistical Programmer position.
Craft a Strong Cover Letter: In your cover letter, express your passion for improving patient outcomes through innovative science. Mention specific projects where you led statistical programming activities and how you ensured compliance with industry standards like CDISC.
Showcase Your Skills: Clearly outline your advanced skills in SAS and your understanding of regulatory requirements. Provide examples of how you've contributed to analysis plans and programming specifications in previous roles.
Highlight Collaboration Experience: Since the role requires effective collaboration with cross-functional teams, include examples of successful teamwork in your application. Discuss how you've built relationships with biostatistics teams or external partners to achieve project goals.
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Showcase Your Technical Skills
As a Principal Statistical Programmer, your advanced SAS skills are crucial. Be prepared to discuss specific projects where you've developed and validated deliverables, and highlight your familiarity with industry standards like CDISC.
✨Demonstrate Collaboration Experience
This role requires effective collaboration with cross-functional teams. Share examples of how you've successfully worked with biostatistics teams or coordinated with internal/external programmers to ensure project success.
✨Understand Regulatory Requirements
Familiarity with regulatory requirements is essential. Brush up on GCP and study procedures, and be ready to explain how you've ensured compliance in past projects, particularly in relation to programming specifications.
✨Communicate Clearly and Confidently
Strong communication skills are vital for this position. Practice articulating your thoughts clearly, especially when discussing complex statistical concepts or project timelines, to demonstrate your ability to negotiate and collaborate effectively.
