Phastar

Senior Statistical Programmer

Phastar

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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

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
  • Familiarity with GCP and regulatory requirements
  • Experience of programming to SDTM and ADaM standards
Benefits
  • Equal opportunities employment
  • Diverse workforce culture
Applicant Tracking System Keywords

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

Hard Skills & Tools
SAS programmingdataset programmingmacro developmentQC of non-statistical outputSDTM standardsADaM standardsstatistical analysis plan (SAP) reviewdefine.xmldefine.pdfprogramming compliance
Soft Skills
leadershipteam collaborationstakeholder persuasiontraining developmentcommunicationproblem-solvingattention to detailresource managementfeedback provisionprocess improvement
Certifications
BSc in Computer ScienceBSc in MathematicsBSc in Science related disciplineGCP certification