UK or Europe
I am currently recruiting for a global biopharmaceutical company. They have nearly 8,000 dedicated staff who are inspired by patients and driven by science help achieve a better life of those suffering from severe diseases. They are the forefront of advancing scientific knowledge and technology and strive for the best. The role is Contract and candidates can be based In UK or In Europe and will be able to work from home.
Job Overview- Statistical Programmer
Provides a high level of effective collaboration for statistical programming initiatives with key team members within GSS and groups outside of GSS (Clinical Data Operations, Technology and Standards (CDOTS), Global Medical Writing, New Medicines, Global Clinical Project Management, therapy areas, Marketing & Market Access and Global Clinical Development & Medical Affairs) to facilitate understanding of statistical programming services and work product.
May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following standard operating procedures and working documents.
Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base
Ensures that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments.
Ensures that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following GSS procedures and standards. Develops specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs. Mentors and trains other statistical programmers as needed.
Supports development and rollout of new standards and processes with respect to own statistical programming operations team.
Ensures compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
Contributes to and manages statistical programming timelines and commitments to timelines for the study and/or project.
• Minimum 7 years in Clinical research field
• Statistic, Computer Science or Software Engineer background education
• Proficiency in SAS macro
• Proved experience in standardization and automation
• Advanced or Proficiency in any high level programming language. (Python, Java, VB, etc…)
• R (is a plus)
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
Job location: London Job salary: £30000 to £40000
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