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Phastar logo
Phastar

Bringing data to life

Principal/Senior Statistical Programmer – MPD

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

Location

India

Posted

69 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGCP

Job Description

Principal/Senior Statistical Programmer – MPD

Phastar

• Program and validate datasets and SDTMs, including complex efficacy, labs, etc. • Become independent technical expert • Program complex non efficacy outputs/ figures • Perform Senior Review and Deliver QC of non- statistical output • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study • Validate and perform User Acceptance Testing (UAT) on standard macros • Identify macros requirements, communicate and perform training • Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc. • Implement and coordinate development and maintenance of PHASTAR standard specifications • Be an SDTM and ADAM expert providing consultancy, advice and training • Be a CRT expert providing consultancy, advice and training • Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements • Implement and coordinate the development and maintenance of PHASTAR CRT tools • Become familiar with and follow study documentation • Initiating projects and ideas for furthering programming development • Ensure the principles in the PHASTAR checklist are followed rigorously • Develop archiving systems and processes • Act as a Lead programmer on multiple studies and 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 • Identify areas where new processes are 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
  • SAS Programming Experience within the pharmaceutical industry
  • Good awareness of clinical trial issues, design, and implementation.
  • Experience of regulatory submissions and associated industry guidance
  • Familiarity with GCP and regulatory requirements
  • Knowledge of SDTM and ADaM CDISC standards

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