Phastar

Principal Programmer, Oncology

Phastar

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Work as a principal programmer across multiple clinical and non-clinical studies
  • Supporting regulatory submission activities
  • Producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines
  • Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area
  • Producing, reviewing and updating complex dataset specifications (including efficacy)
  • Creating and debugging complex macros
  • Reviewing Statistical Analysis Plans (SAPs)
  • Ensuring the principles in the PHASTAR checklist are followed rigorously
  • Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery

Requirements

  • Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
  • SAS Programming Experience within the pharmaceutical industry and experience on Oncology Therapeutic Study
  • 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
Benefits
  • PHASTAR is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce.
Applicant Tracking System Keywords

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

Hard Skills & Tools
SAS programmingCDISC SDTMCDISC ADaMdataset specificationsmacrosStatistical Analysis Plansregulatory submissionsdata validationdata productionclinical trial design
Soft Skills
leadershipindependenceattention to detailtime managementcommunication
Certifications
BSc in Computer ScienceBSc in MathematicsBSc in Science related discipline