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THE COMPANY

PHASTAR is a multiple award-winning, data focused CRO specializing in providing statistics, programming, data management and data science to the pharmaceutical, biotechnology and medical device industries. With offices across the UK, US, Germany, Kenya, Australia, India, China and Japan, PHASTAR is the second largest specialized biometrics provider globally, and the largest in the UK.

Our unique approach to data analysis, “The PHASTAR Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

Senior Statistical Programmer

in India - home-based
Permanent
Start date: As soon as possible
Role and responsibilities

As a Senior Statistical Programmer, you will work on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day-to-day programming activities.

Key Responsibilities:

  • 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 a single large study or multiple smaller studies within same project/portfolio, ensuring quality and timely delivery
  • Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
  • Responsible for study level resources
Experience
  • BSc, MSc or PhD in mathematics, science, or IT related discipline
  • 6 years’ experience working within a clinical trials environment (CRO or pharma)
  • Substantial SAS programming experience
  • CDISC (SDTM and ADaM) experience
  • Previous team lead experience preferred
  • Excellent written and verbal communication skills

To apply, please complete the below application form or, alternatively, submit your CV to recruitment@phastar.com

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