Principal Statistical Programmer job opportunity at Novartis.

Home Jobs In United Kingdom Tag: Job Principal Statistical Programmer position at Novartis


DatePosted 30+ Days Ago bot
Novartis Principal Statistical Programmer
Experience: General
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation London (The Westworks), United Kingdom
loacation London (The We..........United Kingdom

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 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 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.   Job Description 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. Co-ordinate 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

Other Ai Matches

Manager - Forecasting Applicants are expected to have a solid experience in handling Job related tasks
Director, Therapeutic Area Medical Strategy Execution-RLT Applicants are expected to have a solid experience in handling Therapeutic Area Medical Strategy Execution-RLT related tasks
Senior Analyst - BSI Forecasting Applicants are expected to have a solid experience in handling Job related tasks
Principal Clinical Data Scientist Applicants are expected to have a solid experience in handling Job related tasks
Scientist - Analytical Science and Technology Applicants are expected to have a solid experience in handling Job related tasks
Technical Transfer Lead, Medical Device (m/f/d) Applicants are expected to have a solid experience in handling Medical Device (m/f/d) related tasks
Specialist MBR Designer Applicants are expected to have a solid experience in handling Job related tasks
Principal / Senior Principal Biostatistician Applicants are expected to have a solid experience in handling Job related tasks
Tehnolog proizvodnih procesov (m/ž/d) / Process Expert (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Head, Quality Control Applicants are expected to have a solid experience in handling Quality Control related tasks
Quality Assurance Manager (LDC) Applicants are expected to have a solid experience in handling Job related tasks
Assoc. Dir. DDIT DEV CE Sol. Arch. Applicants are expected to have a solid experience in handling Job related tasks
Territory Business Executive-(Institutional Sales)-Chennai Applicants are expected to have a solid experience in handling Job related tasks
Lehre Chemieverfahrenstechnik (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Info Specialist - Literature Intelligence Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Associate Director, Field Launch Excellence Applicants are expected to have a solid experience in handling Field Launch Excellence related tasks
QA Officer Applicants are expected to have a solid experience in handling Job related tasks
Associate Director, Global Publications & Foundational Content Applicants are expected to have a solid experience in handling Global Publications & Foundational Content related tasks
Manager, Innovation Specialist, AI Applicants are expected to have a solid experience in handling Innovation Specialist, AI related tasks
Site Utility Lead Applicants are expected to have a solid experience in handling Job related tasks
VP, M&A Transactions Applicants are expected to have a solid experience in handling M&A Transactions related tasks
Value and Access Lead (Hanoi) Applicants are expected to have a solid experience in handling Job related tasks
Record to Report Sr. Specialist Applicants are expected to have a solid experience in handling Job related tasks