Principal DMC Biostatistician

Job Description

The Principal Biostatistician leads teams of biostatisticians and statistical programmers in creating unblinded reports of confidential, ongoing clinical trial data for DMCs. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.

Responsibilities

RESPONSIBILITIES

• Implements a wide variety of statistical methodologies
• Presents statistical reports to DMCs and clients.
• Provides guidance and oversight of biostatistics and programming teams in production of statistical analyses and reports, including interim analyses and adaptations, for DMCs.
• Ensures blinding and security of data is maintained, as required by contract, charter, or protocol and in compliance with related SOPs and regulatory requirements.
• Serves as primary contact for DMCs.
• Hosts DMC meetings and presents unblinded reports to the DMC in closed meeting sessions.
• Leads and facilitates project team meetings on a regular basis.
• Develops and facilitates internal and external presentations, as appropriate.
• Interact and coordinate with non-DMC Cytel functional groups.
  
  

Qualifications

QUALIFICATIONS

• Master’s degree or PhD in Biostatistics, Statistics, or related field.
• With PhD, a minimum of 6 years of industry experience, with MS a minimum of 8 years of industry experience.
• Expert level knowledge of statistical concepts with working knowledge of medical/scientific terminology
• Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
• Prior unblinded DMC experience required.