Job Details

Lead Statistical Programmer

  • £Competitive
  • Home Based, Italy
  • Permanent
Senior Lead Statistical Programmer | Pharma | Permanent | Home Based | Italy |

Expanding globally this European Pharma who are focussing on developing and commercializing innovative prescription drugs, particularly in the areas of respiratory, rare diseases and specialty care, are looking for an experienced Lead Statistical Programmer to join them.

This is an exciting opportunity for an experienced and ambitious Senior Statistical Programmer, with a background in Statistics, who is looking for a slightly different challenge. This varied role will be a mix between project lead and statistical programming and will involve managing external CROs, performing QC and preparing data packages for FDA submissions.

As a Lead Statistical Programmer you will be responsible for CRO oversight, manage data package preparation for regulatory submissions converting data according to regulatory requirements, preparing integrated analyses and related documentation and performing the QC on the full data package.

What you will be doing.
  • Convert data to CDISC SDTM. 
  • Develop programs to generate analysis datasets (CDISC compliant).
  • Produce datasets documentation according to CDISC and FDA requirements using define.xml and/or to review analysis datasets documentation prepared by providers.
  • Develop programs to produce tables, listings, and figures.
  • Develop macros and programs for data quality evaluation and to develop data quality reports.
  • Writing, documenting, and performing quality control review of programs.
  • Perform ad hoc analysis for various statisticians’ requirements.
  • To archive data, metadata and programs in the relevant area during the ongoing of the trial and to create the frozen version of the above documents on the database lock and full statistical output version.
  • Prepare and/or to review the data package for a submission to regulatory authorities, leading the activities when performed internally or by an external provider.
  • 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.

What you will need:
  • MS/MA degree in a related field including health science, statistics, or maths.
  • Good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS on Windows.
  • Proficient in Macro Facility
  • Extensively involved in clinical data analysis and preparation of Data sets, Reports, Tables, Listings, Summaries and Graphs according to Standard Operating Procedures (SOPs).
  • In depth understanding of CDISC standards and SDTM & ADaM.
  • General knowledge of statistical methods essential.
  • Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.
  • Involved in the process of generating TLGs (Tables, Listings and Graphs) for ISS and ISE for FDA submission.
  • Knowledge of R, Phython or any other open-source tool for the data analysis and data visualization highly advantageous.

What’s in it for you:
  • Work for a dynamic Pharma who have a strong investment in innovation with collaborative and inspirational working environment.
  • Opportunity to attend annual conferences abroad.
  • 2023 – 2024 Best Pace to work Europe Winners!  
  • Competitive salary and benefits package.
  • Fully home based in Italy or across Europe.

What to do next:
If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the Lead Statistical Programmer onboard as soon as possible.

Not what you’re looking for?
Please contact Jo Fornaciari on +44 (0) 7488 822 859 for a confidential discussion about potential opportunities.

Jo Fornaciari Principal Consultant in Statistical Programming

Apply for this role

© Warman O'Brien 2023
Site by Venn