Associate Director, Biostatistics

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. ( Positions available supporting multiple Therapeutic Areas available )

Main Responsibilities:

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
  
• Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
  
• Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.

• PhD with 8 years of experience or MS with 11 years of experience in drug development
  
• Experience providing statistical leadership at compound/indication level
  
• Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
  
• Solid experience in applications of advanced statistical methodologies
  
• Leading roles in regulatory submissions
  
• Experience in interactions with major regulatory authorities preferred
  
• Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
  
• Track record of innovation preferred
  

• Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes
  
• Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English)
  
• Good working knowledge of SAS and/or R
  
• Expertise in a range of statistical methodologies
  
• Demonstrated use of innovative / creative methodology for analysis of clinical data
  
• Familiarity with relevant regulatory guidance documents
  

• CDISC, statistical programming, and/or data standards
  
• Biostatistics and Statistical Programming Operations