eClinical Solutions

Manager, Statistical Programming

eClinical Solutions

full-time

Posted on:

Location Type: Remote

Location: MassachusettsUnited States

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Salary

💰 $136,000 - $170,000 per year

Job Level

About the role

  • Determine resourcing needs per project load, deadline requirements and resource utilization
  • Create or review and approve programming plans at study and project level
  • Provide input on key study-related documents produced by other functions
  • Responsible for developing and maintaining programming and validation specifications for TLGs
  • Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials
  • Assist Biostatisticians by suggesting algorithms to address novel analysis requests
  • Develop analysis datasets for trial level reporting and integrated safety and efficacy activities
  • Program and QC data listings, summaries and Graphs as defined in SAP
  • Develop re-usable utility macros to build a macro library
  • Create submission-ready SDTM and ADaM datasets
  • Perform peer review of all SAS Programmers’ deliverables
  • Serve as Subject Matter Expert for Statistical deliverables
  • Collaborate with the project team and other Professional Services Managers
  • Develops and maintains good working relationships with internal cross functional teams and Clients
  • Develops, revises, and maintains Standard Operating Procedures and Work Instructions
  • Maintain all project documentation as required by SOP and Processes
  • Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
  • Champion the evolution of statistical programming through automation and advanced analytics using elluminate®
  • Lead internal initiatives focused on standards governance
  • May serve as Lead Statistical Programmer on projects when needed

Requirements

  • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field and/or equivalent work experience preferred
  • 8+ years’ experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
  • 2+ years of leadership, supervisory, or technical lead experience preferred
  • Excellent knowledge of English
Benefits
  • Pay Range
  • US Pay Ranges
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

Applicant Tracking System Keywords

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

Hard skills
SAS programmingprogramming plansvalidation specificationsanalysis datasetsdata listingsutility macrosSDTM datasetsADaM datasetspeer reviewadvanced analytics
Soft skills
leadershipcollaborationrelationship buildingcommunicationproblem-solvingattention to detailorganizational skillsinitiativeadaptabilityteamwork