Experienced Statistician, Epidemiologist and Data Manager with a demonstrated history of working in both academia and Pharma. Skilled Analytical Skills, Statistical Data Analysis and Good Clinical Practice (GCP).
Skills:
• Efficient and accurate data entry, cleaning, analysis, interpretation and archiving.
• Ability to work with close attention to detail, scrutinize the validity of the data being entered and has the ability to phrase data queries in a clear and impartial manner.
• Computer literate and numerate with the ability to adapt to various computer systems.
• Advanced knowledge analysis skills using STATA and basic R.
• Ability to create well performing risk adjustment and prediction models
• Database creation and management using SQL
• Experience of phase II & III clinical trial set-up, maintenance and close out activities
• Working knowledge of various epidemiological databases: HES, CPRD, ONS, SACT, RTDS.
• Support the development of protocols, Standard Operating Procedures (SOPs), Statistical Analysis Plans (SAPs).
• Ensure adherence to GCP, GDPR and regulatory guidelines,
• Experience with Clinical Data Management systems (Medidata Rave, Oracle InForm, ClinTrial)
• Capacity to work independently and multi-task
• Excellent communication with various stakeholders
• Regulatory submissions (CAG/ DSA/REC)
Keywords:
Statistical analysis/ STATA/ SQL/ Microsoft Excel/ Data Management/ Database design/ Database management/ Observational studies/ Epidemiology/ Statistical analysis plans/ Data entry/ Data cleaning/ GDPR/ ICH GCP/ Phase II & III clinical trials/ Research/ Research projects/ Clinical trials management/ Automated reporting/ SSRS/ Microsoft Access