Novartis

Senior Principal Statistical Programmer

Novartis

full-time

Posted on:

Location Type: Hybrid

Location: Basel • Switzerland

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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
  • Oversees programming style, quality of statistical reporting & compliance with timelines
  • 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
  • Co-ordinate activities of programmers either internally or externally
  • Make statistical programming decisions and propose strategies at study or project level
  • Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities

Requirements

  • 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
Benefits
  • Flexible working arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASstatistical programmingadvanced MACROsstatistical analysis planstechnical programming specificationsdata validationdataset developmentregulatory submissionsclinical trial programmingCDISC data structures
Soft Skills
communication skillsnegotiation skillscollaborationinfluenceteam coordinationknowledge transferstrategic partnershipquality assurancetimelinessproblem-solving