Senior Principal Statistical Programmer

Novartis; London; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An innovative company is on the lookout for a Senior Principal Statistical Programmer to tackle HTA challenges and optimize drug development processes. This exciting role involves leading statistical programming for clinical trials, ensuring high-quality deliverables while collaborating with cross-functional teams. With a focus on process improvements and compliance, you'll play a pivotal role in shaping the future of healthcare. If you are passionate about making a difference in patients' lives and have extensive experience in statistical programming, this opportunity is perfect for you.

Qualifications

• 7+ years experience in statistical programming within the pharmaceutical industry.
• Strong programming skills in R/R Shiny, with Python and SAS as a plus.

Responsibilities

• Lead statistical programming activities for clinical projects across phases I to IV.
• Ensure compliance with project standards and regulatory guidelines.

Skills

Statistical Programming

R/R Shiny

Python

SAS

Negotiation Skills

Collaboration Skills

Education

Bachelor's in Statistics

Master's in Statistics

Equivalent in Computer Science/Mathematics

Job description

Join to apply for the Senior Principal Statistical Programmer role at Novartis

We are seeking a Senior Principal Statistical Programmer with expertise in HTA, RWE, HEOR, and Pricing and Reimbursement activities. This role involves providing statistical programming solutions to HTA challenges, collaborating closely with International Value & Access and HEOR teams to optimize processes for Joint Clinical Assessment in Europe, ensuring high-quality deliverables.

The Senior Principal Statistical Programmer will oversee all statistical programming aspects of multiple studies or projects, acting as a strategic partner to ensure efficient execution of drug development plans with high-quality, timely deliverables. Responsibilities include ensuring compliance with project standards and regulatory guidelines, overseeing programming quality, and leading process improvements.

Key Responsibilities

1. Lead statistical programming activities for medium to large projects across clinical phases I to IV.
2. Coordinate activities of internal and external programmers, making strategic programming decisions.
3. Possibly serve as a functional manager, supervising and advising programmers.
4. Collaborate with cross-functional teams on deliverables, timelines, scope, and resources.
5. Review data collection forms, data structures, and ensure standardization for pooling and efficient analysis.
6. Ensure timely development and validation of datasets and outputs for reports, regulatory submissions, safety reports, publications, and exploratory analyses.
7. Maintain quality control and audit readiness of all programming deliverables.
8. Lead process improvement initiatives related to programming and reporting.

Qualifications and Experience

• Fluent in English, with strong negotiation and collaboration skills.
• Bachelor’s, Master’s, or equivalent in statistics, computer science, mathematics, or related fields.
• Strong programming skills in R/R Shiny; Python and SAS are desirable.
• Experience with late-phase studies, RWE, and HEOR preferred.
• At least 7+ years supporting clinical trials or within the pharmaceutical industry.
• Experience with statistical analysis plans, CDISC standards, and regulatory requirements.
• Proven ability to lead teams and coordinate multiple studies/projects.

Additional Details

• This role is hybrid, requiring 3 days/week in London.
• Join a community committed to diversity, inclusion, and making a difference in patients' lives.
• Benefits and further info available at Novartis careers portal.