Responsibilities: Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies. Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS. Create and review annotated CRF to STDM datasets. Produce and maintain technical programming specification documents. Lead and actively participate in client and project review meetings. Communicate with clients regarding study protocol or statistical analysis issues. Validate statistical deliverables and ensure that appropriate statistical methods are utilized. Ensure adherence to industry standards and regulatory requirements. Facilitate the development and application of adequate statistical methods in clinical research. Requirements: PhD or MS degree in Statistics, Biostatistics, or related field. 5+ years of relevant work experience in CRO, biotech, pharmaceutical, or life sciences industry. Familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines (FDA/EMA, ICH/GCP). Experience with NDA/BLA submission activities. Experience in statistical programs such as Statistical Analysis System (SAS), CDISC and SDTM. Understanding of Ultra Compare software. Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and Standard Operating Procedures (SOP's). Excellent organizational skills, time management, ability to prioritize workload, and meet deadlines. Excellent communication and interpersonal skills to effectively interact with others. Katalyst Healthcares and Life Sciences
...Job Title: Change Enablement Manager Location: Pleasanton, CA Duration: 10+ months Job Description - Client is seeking a passionate and forward-thinking change enablement specialist to be part of our newly-formed Global Marketing Operations Design team. This...
...ll play a pivotal role in driving organic growth and enhancing online visibility. Your responsibilities will include: Conducting... ...boosting organic traffic. Optimizing website content to improve search engine rankings for targeted keywords and phrases. Performing...
...compassionate individuals to apply to join our amazing team as a part-time or full-time Caregiver ! Compensation: $14-$16 WHY... ...ARE YOU A GOOD FIT? Ask yourself: Do I enjoy working with senior citizens? Can I provide compassionate elderly care with a positive...
I am the owner of a 7 car enclosed trailer with tractor that will be used for hauling vehicles including, but not limited to SUV's,... ...I am looking to hire an eager, experienced enclosed car hauler/driver for interstate car hauling. Employee is expected to be flexible...
...serve a quality product with world-class customer service. As a Barista, you'll be the one to hand-craft our customers' espresso... ...and the drive-thru station. Requirements Previous experience is preferred, though not necessary; we will provide you the training...