Manager, Biostatistics REF9001X

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Essential Functions Include:

• Serves as a lead statistician on ProPharma Group projects.  
• Ensures the quality and timeliness of biostatistics deliverables.  
• Provides leadership to biostatistics teams and projects to achieve organizational and client objectives. 
• Ensures appropriate staffing, training, and adherence to SOPs including effective validation practices for ProPharma Group's Biostatistics teams. 
• Responsible for financial management of assigned projects/programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaising with finance group as needed. 
• Maintains knowledge of regulatory guidelines and industry standards as applicable to clinical studies with specific emphasis on biostatistics activities. 
• Participates in the development and maintenance of the ProPharma Group standards and templates within regulatory requirements.  
• Assists in developing and/or implementing strategies and policies for biostatistics services aligned with maximizing quality and reliability of deliverables at an optimized cost.
• Assists in the creation and maintenance of biostatistics related SOPs.  
• Performs other work-related duties as assigned.

Qualified candidates must have:

• Minimum: Master’s degree in statistics, mathematics, or a related science discipline.     
• Minimum 3 years’ experience in Biostatistics for clinical trials in a CRO environment.  Experience with FDA submission is preferred.    
• Experience managing multiple Biostatistics related resources at one time across multiple projects.  
• Knowledge of CDISC standards (SDTM, ADaM and Define.XML).  
• Knowledge of the FDA Common Technical Document for Data Standards.  
• Strong understanding of the ICH and GCP regulatory requirements.  
• Strong understanding of advanced statistical methods.  
• Strong project management skills and technical aptitude. 
• Strong skills in SAS programming.  
• Strong written and verbal communication skills.  
• Ability to write and present information effectively.  
• Self-Motivated.

• All candidates must be legally eligible to work in the United States. 
• ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***