Description
Key Responsibilities:-Review statistical sections of protocols, writing statistical analysis plans, and developing SAS programs.
-Generate randomization schedules and provide sample size.
-Provide input into the development of CRFs.
-Author statistical analysis plans, including development of table and listing shells.
-Review statistical analysis plans written by other Biostatisticians.
-Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
-Perform quality control for SAS programs and other study documents.
-Review output across programs to ensure consistency.
-Prepare statistical sections of clinical study reports.
-Interact directly with clients.
Desired Experience:
-MS or degree in Statistics and a minimum of 5 years relevant industry experience.
-Knowledge of industry standards, such as ICH guidelines, CDISC data structures, 21 CRF Part 11, and FDA guidelines.
-Experience with SAS.
-Experience leading projects with excellent organizational skills, time management, and ability to coordinate workload and meet established dealines.
This is a great opportunity to truly make a difference, bringing new treatments to patients with your vast statistical skills, and providing expertise to support fellow colleagues throughout all phases of clinical development. To be considered for an interview, please send over your updated resume and contact me immediantly. I look forward to discussing with you further.
Best,
Joyce
Keywords:
Biostatistician, Biostatistics, San Diego, California, Rare Diseases, CDISC, FDA, CRF, ICH, SAS, Statistics, Pharmaceutical, Biotechnology, Medical Device, CRO