Phastar

Principal/Senior Statistical Programmer – MPD

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.
  • 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

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
Applicant Tracking System Keywords

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

Hard Skills & Tools
SAS ProgrammingSDTMADaMUser Acceptance Testingmacro developmentdataset specificationsQCdata validationprogramming outputsarchiving systems
Soft Skills
leadershipcommunicationtrainingpersuasionproject managementproblem-solvingcollaborationinitiativeattention to detailstakeholder engagement
Certifications
BSc in Computer ScienceBSc in MathematicsBSc in Science related discipline