Introduction

Introduction

We are currently hiring a Statistical Programmer (full-time, remote) for our client, a global pharmaceutical company and one of the largest pharmaceutical companies in the world. The company is known for its success in researching developing and marketing innovative drugs.

The Statistical Programmer will be responsible for the development of SAS programs and statistical output for the management and reporting of clinical trial data managed by the Unit. Ensure quality of statistical output produced by external provider, programs tools to support data review activities and data visualization and collaborate on the interpretation and communication of trial results. By contributing to regulatory submissions, converting of data according to regulatory requirements, preparation of integrated analyses and related documentation, the Statistical Programmer will play a strategic role in the Clinical Development Projects they are involved in. They will also support the development of standard operating procedures, performs post-hoc analysis for exploratory purposes, or supports regulatory requests, and prepares analysis for paper publications.

What are you going to do

Responsibilities

  • To convert data to CDISC SDTM, following project specifications
  • To develop SAS programs to generate analysis datasets (CDISC compliant)
  • To produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providers
  • To develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lock
  • Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports
  • Writing, documenting, and performing quality control review of SAS programs
  • To perform ad hoc analysis for various statisticians’ requirements
  • To support statisticians in the preparation and/or review and QC of statistical package for FDA submissions
  • To perform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with international requirements and with internal SOP/Standards

Essential skills and knowledge 

Requirements

  • Bachelor's Degree in Statistics or Health Sciences/Computer Science is required
  • SAS certification and/or A. Stat or P. Stat accreditation are assets
  • 4+ years of experience in Pharma or CRO is required
  • Previous SAS experience and expertise is required
  • Previous experience with Data Management and Biostatistics processes.
  • In-depth understanding of CDISC standard
  • Proficient in MS Office (Word, Excel, Project, PowerPoint)
  • Proficient in relational databases

What we offer

What We Offer

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