Summary

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.

About The Role

Major accountabilities:

• 1. 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.
• 2. 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.
• 3. 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).
• 4. Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.
• 5. 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.
• 6. Provide and implement statistical programming solutions; ensure knowledge sharing.
• 7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.
• 8. 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.
• 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• 10. 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.
• 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
• 12. As assigned, act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures.
  
  

Key Performance Indicators (Indicate how performance for this job will be measured) :

• Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Program Statistician and the functional/operational manager.
• Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members.
• Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager.
  
  

Job Dimensions (Indicate key facts and figures) Number of associates:

No direct reports. Coordination of 5+ internal and external programmers. Financial responsibility: (Budget, Cost, Sales, etc.) None Impact on the organization:

• Timely, high quality and efficiently produced statistical programming deliverables included in study and project level documents (incl. submissions)
• Reliable and compliant statistical analysis results presented externally (incl. submissions)
• Innovative technical solutions to support timely and efficient drug development deliverables Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Languages: Fluent English (oral and written).
  
  

Experience/Professional Requirement

• 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
• Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry
  
  

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