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Associate Director, Biostatistics - Simply Biotech

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Associate Director, Biostatistics- Simply Biotech  
OVERVIEW  
  
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.  
  
Immediate opening for an Associate Director, Biostatistics with a biopharmaceutical company in Washington, DC who possesses:   
  
  • PhD Biostatistics or Statistics 
  • 4+ years of clinical trial experience within pharmaceuticals, along with an in-depth understanding of regulatory requirements and methodology 
  • Expertise in SAS and R 
 
Email resumes to aencarnacion@simplybiotech.com or call 858.427.3668 
  
FULL DESCRIPTION:  
 
The selected candidate will be responsible for: 
  • Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) 
  • Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups 
  • Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others 
  • Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities 
  • Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected 
  •  Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed 
 
The selected candidate will also possess:  
 
  • Ph.D. in Biostatistics or statistics 
  • At least 4 years of pharmaceutical clinical trial experience 
  • In-depth knowledge of clinical trials methodology, regulatory requirements, statistics 
  • Comprehensive experience of SAS programming and R/S language 
  • Ability to effectively collaborate in a dynamic environment 
  •  Excellent practical, organizational, interpersonal, oral and written communication skills are a must 
 
 
Salary Range: $175k-$225k/yr 
  
For immediate and confidential consideration, please email your resume to aencarnacion@simplybiotech.com or call 858.427.3668. More information can be found at www.simplybiotech.com