About You
Responsibilities:
You will provide statistical support across a range of development products working cross-functionally with Clinical Development, Medical Affairs, and Safety. In addition, you will be responsible for providing statistical inputs and lead all statistical activities for assigned projects/programs and plan and manage statistical analyses according to the project timelines.
Tasks:
• Provide statistics input into trial development activities, such as study design, sample sizing and protocol.
• Manage outsourced biometrics activities such, as creation of SAP, ongoing data reviews, trial progress, DSMB/DMC meetings, and reporting of clinical studies.
• Manage, perform, review, and interpret the statistical analyses for our key customers: Regulatory Affairs, Medical Affairs, Drug Safety, and Clinical for the preparation of publications, documents, and other communications.
• Continued development and implementation of more efficient Statistical & Reporting practices.
Qualifications:
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
Minimum Requirements
• Educated to MSc or higher level in a statistics discipline
- More than 10 years of clinical trials experience
• Experience in phase III and IV clinical trials
• Experience in the planning and execution of clinical trials incorporating adaptive design elements such as interim analysis and sample size re-estimation
• Strong SAS programming experience
• Knowledge of CDISC and CRO management
Preferred Requirements
• Excellent communication skills in English
• Exposure to regulatory agencies
• Exposure to Medical Affairs activities
• Proactive and enthusiastic team player
• Demonstrable experience of working in cross-functional teams to achieve drug development goals
PLEASE NOTE:
As a federal contractor, Vifor Pharma, Inc. is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason, a genuine religious belief, on an individual basis in accordance with applicable legal requirements. All employees must be in compliance with Vifor Pharma, Inc.’s COVID-19 vaccine policy at the commencement of their employment.