Principal Biostatistician - Priovant Therapeutics

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The PrincipalBiostatisticianwill help advance this mission byproviding statistical support and operational oversightof the design, execution and analysis of assigned clinical studies. S/he will report to theDirector, Biostatistics.  

Responsibilities 

• Serve as the lead statistician for assigned clinical trials, providing statistical input for all aspects of a clinical study, e.g.,  
  • clinical study design  
  • protocol development  
  • CRF review  
  • study specific documents and plans, including review and approval of randomization specifications and development and execution of the Statistical Analysis Plan (SAP) 
  • statistical analysis of primary endpoint and other key endpoints  
  • statistical interpretation of the results and input into clinical study report)  
  • provide periodic hands-on programming support  
• Provide oversight of deliverables from CROs by ensuring the statistical tasks are completed and delivered in accordance with timelines and data quality standards 
• Effectively collaborate with cross-functional team members to provide statistical guidance and explain statistical concepts in an easily understandable way.   
• Provide statistical support for regulatory submission as needed 

Qualifications  

• PhD (in Statistics/Biostatistics or equivalent) with 3+ years relevant experience or MS (in Statistics/Biostatistics or equivalent) with 7+ years relevant experience 
• Experience providing statistical support for a clinical study (protocol development, SAP development and execution, validation of primary analysis, interpretation of results, review of CDISC datasets, and input into the study report) 
• Proficient in SAS and its statistical procedures (non-parametric analysis, linear and non-linear modeling, categorical data and survival analysis). 
• In-depth knowledge of the clinical development process and relevant regulatory guidance 
• Strong organizational skills and conscientious attention to detail 
• Hands-on, roll-up-your-sleeves attitude, with a sense of urgency and drive for results  
• Excellent communication, problem-solving, and decision-making skills  
• Natural collaborator who enjoys working on a cross-functional team