Senior Principal Statistical Programmer

Novartis AG; City of Westminster; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in the United Kingdom is seeking a skilled Statistical Programmer to lead programming activities for clinical studies. The successful candidate will have expert experience in SAS and a strong understanding of regulatory requirements and industry standards. You will collaborate with cross-functional teams and ensure high-quality deliverables throughout the drug development process. If you are passionate about improving people's lives through innovative medicines, this role is for you.

Benefits

Personal and professional growth support

Diversity and inclusion commitment

Qualifications

• Minimum 3 years experience in a programming role, preferably in clinical trials.
• Advanced knowledge of industry standards including CDISC data structures.
• Experience as Trial/Lead/Project Programmer for multiple studies.

Responsibilities

• Lead statistical programming activities for multiple studies.
• Build effective relationships with cross-functional teams.
• Ensure compliance with company and industry standards in programming.

Skills

Expert SAS experience

Proven communication and negotiation skills

Ability to work with cross-functional teams

Understanding of regulatory requirements

Education

BA/BS/MS in statistics, computer science or related field

Tools

SAS

Job description

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.

Responsibilities

• 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.
• 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.

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.

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

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