location_onBengaluru, Karnataka, India
watch_later Posted: Apr 08, 2024
Skills Required
Nice To Have skills
Job Description
About the job
- As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings
- Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate
- Preparation of Statistical Analysis Plans (including mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff
- Perform statistical analysis for medium complexity studies
- Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery
- Review CRF and other study specific specifications and plans May perform sample size calculation for Clinical Pharmacology studies under the supervision of senior statistical staff
- Provide statistical input and review of the CSR for simple studies
- Generation and review of randomization schedules from provided specifications under the supervision of senior statistical staff