Principal Statistical Programmer
Sandoz Canada
Geneva, Switzerland
vor 9 Tg.

Job Description

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 AAA Global Development.

Major activities

  • 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 AAA Global 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.
  • Minimum requirements

  • BA / BS / MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
  • 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
  • Fluent English (oral and written).
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