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Job Description

Sr. Principal to Associate Director Biostatistics Oncology (DG)

North NJ, Major Pharma.

Base salary up to $140,000 depending on experience.

Description:

•  

  • Review protocols and case report forms for trial design.

  • Write statistical methodology of the protocol.

  • Prepare analysis plan and programming specifications.

  • Perform inferential analyses.

  • Write the statistical section of the clinical trial report and review clinical trial report.

  • Support/participate in drug project related activities including preparation of global HA submissions.

  • Oversee CRO deliverables for trials contracted out.   

Job Requirements

 

• PhD in statistics with 5 years of pharmaceutical experience (7 years for AD level) .

   

• Strong statistical and data analysis skills; strong knowledge of statistical and clinical trial methodology.

   

• Solid hands-on experience as statistician in clinical development program.

   

• Good knowledge of drug development process.

   

• Experience in supporting NDA submissions.

   

• Strong ability in protocol development, analyses and clinical trial reports/publications of Phase I-III clinical trials. Very good oral and written communication skills.

   

• Knowledge of FDA/ICH guidelines.

   

• Good knowledge of SAS, S-Plus computer packages.

   

• Good project management skills.

   

   

   

  Please send your resume in Word format Darren Gutowski at [Click Here to Email Your Resumé] CLARK DAVIS ASSOCIATES, 20 Waterview Blvd., Parsippany, NJ, 07054; Phone (973) 257-8825; Fax (973) 8824

                                                                                                                                      

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