CSL

Principal Programmer

CSL

full-time

Posted on:

Location Type: Office

Location: King of Prussia • Massachusetts • Pennsylvania • United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content.
  • Plans and leads the production and validation efforts for the designed output, this may include oversight of work by CROs.
  • Collaborates with study teams to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
  • Supports the review of related deliverables when provided by CROs.
  • Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.
  • Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO
  • Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
  • Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
  • Works closely with clinical study teams to execute activities to ensure project timelines are met with high quality deliverables.
  • Additional tasks: Collaborates with CR&D staff regarding data analysis requests.

Requirements

  • Education: BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
  • Other degrees and certifications considered if commensurate with related programming experience
  • At least 8 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
  • Indepth understanding of clinical programming and/or statistical programming processes and standards.
  • Indepth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
  • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
  • Strong programming and problem-solving skills.
  • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
  • Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
  • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
  • Experience in working in cross-functional, multicultural and international clinical trial teams.
Benefits
  • For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
Applicant Tracking System Keywords

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

Hard Skills & Tools
SASSAS MacrosCDISC ADaMCDISC SDTMCDISC CDASHstatistical programmingclinical programmingdata analysisdata structure designvalidation efforts
Soft Skills
problem-solvingcollaborationleadershipcommunicationtime managementindependenceteamworkattention to detailorganizational skillscross-functional collaboration
Certifications
BSc in Computer ScienceBSc in MathematicsBSc in StatisticsGCP certificationICH certificationCDISC certificationclinical programming certificationstatistical programming certificationdata analysis certificationproject management certification