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Principal Statistical Programmer

3 weeks ago

Manchester, United Kingdom Hays Specialist Recruitment Limited Full time

Excellent work/life balance, Renowned company culture, Tremendous progression Opportunities
**Your new company**
Would you like to join a cutting edge CRO who truly put their people at the forefront of everything they do?
HAYS have partnered with a solely Biometrics focused Contract Research Organization who are searching for a Principal Statistical Programmer.
The business are undergoing unique expansion plans with tremendous investment and growth being placed on every area of the business. As mentioned, the business truly put their people first especially from a development/progression standpoint holding a renownedreputation for developing junior and experienced Statistical Programmers throughout all aspects and allowing you to decide your own career whether that be a line management position, technical SME, project lead/oversight etc.
Under the expansion plans, there are two very exciting opportunities for a Principal Statistical Programmer to join within the companies Internal team which is a traditional CRO model working with multiple clients and gaining a wealth of experience across differentTA's, processes etc. The other lies within the companies FSP function which would see you fully embedded within a leading Global Pharma and develop your skillset from that perspective.
**Your new role**
Either department allows you to have a true impact on the studies you are working and the lack of 'red tape' within the business will allow you to fully flourish. Please see below an overview of responsibilities:

- Perform the lead programming role, responsible for planning and delivery of all study programming activities including programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and program validation for specific studies
- Ensure the maintenance of documentation
- Produce ad hoc data summaries when requested during the course of a trial.
- Liaise with internal departments, sponsors and other third parties to ensure all delivery requirements fulfil client needs.
- Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations.
- Lead role in identifying system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
- Provide consultancy to CDM, Programmers and Statisticians on programming and associated software support.
- Assist with Quality Assurance and Audit requirements
- Perform all activities in compliance with company and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).

**What you'll need to succeed**
- Proven experience as a Statistical Programmer within a CRO, Pharma, Biotech or Medical Device company
- Strong SAS Programming skillset
- Knowledgeable of CDISC, SDTM and AdAM
- Previous experience working in a project lead role
- Keen interest in taking ownership of your career path

**What you'll get in return**
- Wealth and various opportunities to progress your career
- Working with a technically brilliant and innovative department
- Work alongside expert statistical programmers
- Fully remote based positioning
- More than competitive financial package

**What you need to do now**
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.