Director of Biostatistics job in Tarrytown, NY

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Matthew Masterson
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Director of Biostatistics job in Tarrytown, NY

 The Director of Biostatistics will be responsible for providing leadership and statistical input into all of the clinical development programs. He/she will be responsible for managing simultaneous projects and must have a proven track record to be flexible, proactive, and collaborate skillfully and effectively with other functional areas. He/she will oversee the programming and data management staff and must possess the ability to provide clear direction and mentorship. A hands-on approach is necessary to support the clinical group’s statistical needs with regard to data analysis, for interacting with CROs, and for preparing study-level analyses as required for presentations and submissions. He/she must have excellent writing skills and the ability to explain complex statistical results in a clear and concise manner. 

The major functions to be performed in this position are as follows: 
• Write and review statistical analysis plans; contribute statistical input for CRFs; prepare sample size estimation for trials 
• Ensure data integrity, statistical analyses and result interpretation 
• Write/review statistical sections of NDAs, INDs, etc., as appropriate 
• Manage process with in-house programmer; review the programs they write 
• Provide statistical input to data management process 
• Prepare and present presentations for expert meetings; attend and address questions 
• Serve as biostatistics representative for regulatory activities, such as FDA interactions and discussions, NDA preparation and submission, etc. 
• Contribute to publications and abstracts 
• Program statistical analyses 
• Interface with biostatistical vendors

Education: Ph.D. or equivalent 
Preferred major: Biostatistics 

Minimum Experience Requirements: 
Candidates being considered for this position should possess: 
• Minimum of 5-7 years relevant work experience in pharmaceutical industry or CRO biostats group 
• Have full working knowledge and practical experience supporting clinical teams to design protocol endpoints and to write statistical methods sections of protocols including sample size calculations 
• Experience writing statistical analysis plans, data analysis, and generating tables, listings and graphs for clinical study reports 
• Experience generating patient profiles and creating post-hoc analysis tables and graphs 
• Experience with statistical input of CRF design and programming specifications 
• Experience with managing direct reports 
• Experience with Phase 2 and Phase 3 drug development 

Knowledge and experience in the following areas: 
• SAS analysis programming skills essential (SAS/Stat, graph, macro) 
• Experience with other statistical software and graphics packages a plus 
• Excellent communication skills and technical writing experience

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