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Phastar

Bringing data to life

Senior Programmer

Software EngineerSoftware EngineerFull TimeRemoteSeniorTeam 201-500Since 2007H1B SponsorCompany SiteLinkedIn

Location

India

Posted

104 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGCP

Job Description

Senior Programmer

Phastar

• Program and validate datasets and SDTMs, including complex efficacy, labs, etc • Program complex non efficacy outputs/figures • Perform Senior Review and Deliver QC of non-statistical output • Develop and debug complex macros • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study • Create, QC and update complex dataset specifications (including efficacy) for single/multiple studies, ISS/ISEs, etc • Review more complex study design SAP without supervision • Review all shells without supervision and provide feedback • Knowledge, interpretation and implementation of current SDTM, ADAM standards • Knowledge of FDA CRT requirements including define.xml and define.pdf • Lead team and be responsible for creation of CRT packages • Become familiar with and follow study documentation • Lead a team for furthering programming development • Ensure the principles in the PHASTAR checklist are followed rigorously • Archive study documentation following instructions in supplied SOPs • Act as a Lead programmer on multiple studies under same project, ensuring quality and timely delivery • Liaise with Study Statistician and Project Manager regarding resourcing and deliverables • Responsible for study level resources • Attend and input to company resourcing meeting • Point of contact for programming issues for the team, proactively ensuring everything is working cohesively • Persuade stakeholders to follow best practice within a trial • Develop and deliver company-wide training as and when required • Create, review and update processes and SOPs • Take responsibility for study compliance with SOPs and processes

Job Requirements

  • Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
  • 5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs)
  • 5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential)
  • Oncology experience is preferred
  • Excellent communication skills
  • Good awareness of clinical trial issues, design, and implementation
  • Familiarity with GCP and regulatory requirements

Benefits

  • Flexible working
  • Part-time hours
  • Involvement in developing company-wide initiatives
  • Structured training and development plans
  • Supportive, fun, and friendly environment
  • Tree planting initiative as part of ESG initiatives

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