Senior Principal Statistical Programmer

Healthcare Businesswomen’s Association; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading healthcare organization in Greater London seeks a Senior Principal Programmer to lead statistical programming for clinical trials. Responsibilities include overseeing programming quality, ensuring timely deliverables, and collaborating with biostatistics to support drug-development plans. Candidates should have a degree in statistics or a related field, significant SAS and programming experience, and a solid understanding of regulatory requirements. Join us to make a difference in patient lives through innovative solutions.

Qualifications

• Work experience in a programming role in clinical trials or the pharmaceutical industry.
• Proven experience in development of advanced MACROs.
• Good understanding of regulatory requirements relevant to Statistical Programming.

Responsibilities

• Lead statistical programming activities for several studies.
• Ensure timely and quality development of datasets for regulatory submissions.
• Comply with industry standards and assess programming requirements.

Skills

SAS expertise

Statistical analysis

Programming languages

Data structures

Clinical trials experience

Communication skills

Education

BA/BS/MS in statistics or related field

Tools

SAS

MACROs

Job description

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.

Job Description

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 summarise 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 standardisation 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.

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross‑Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis