Job DescriptionThis is an excellent opportunity for a Statistical Programmer who has experience with SDTM/ ADaM, to join a pioneering Biotech based in Worthing, Sussex. This is a newly created role resulting from studies which have been traditionally been outsourced being brought inhouse. This role will offer someone who loves harmonising datasets a truly fascinating opportunity with plenty of scope for progression.
• Organising historical datasets into an acceptable harmonized format and to create consistency across existing and future studies.
• Contribute to the preparation and delivery of standardized (e.g. CDISC/SDTM/ADaM) datasets required by regulatory authorities for submissions.
• Preparation of graphs, tables and listings for inclusion in clinical study reports.
• Support the independent programming of the primary endpoint and key secondary endpoints for clinical trials.
• Production of ad-hoc data summaries, data listings and study data sets to identify outliers and support the data cleaning process, if required, during the course of a clinical trial.
• Responsible for production and maintenance of technical database standards and programming of specification documents, applying high standards of good programming practice.
• BSc in Mathematics, Statistics, Computer Science or related field.
• At least 3 years’ experience within a similar programming role.
• At least 2 years of SAS programming experience in creating SDTM/ADaM and TFLs within a clinical trial environment (Pharma, CRO or biotech).
• Knowledge of CDSIC standards and industry best practices
• German speaking skills would be an asset, but not essential.
This role can be remotely based, but will require some office attendance on a weekly basis.