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Phastar

Senior Statistical Programmer

Phastar

Senior Statistical Programmer developing complex datasets and outputs for clinical trials at PHASTAR. Leading programming efforts and ensuring compliance with statistical standards and quality deliverables.

Posted 4/14/2026full-timeRemote • 🇮🇳 IndiaSeniorWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • 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

What you’ll need
  • 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

Comp & perks
  • Equal opportunities employment
  • Diverse workforce culture

ATS Keywords

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Applicant Tracking System Keywords

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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