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Study Lead Statistician

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    
  • 5+ years of clinical trials experience.
  • Hands on SAS experience is required.
  • Regulatory interaction payer experience.

Day to Day Responsibilities:    
Position Summary:

The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.

Responsibilities:
  • Perform all duties and responsibilities associated with the Study Lead Statistician role
  • Attend Clinical Study Team meetings and provide all required statistical input related to strategy and operations of the clinical study.
  • Plan and execute statistical contributions to Study Outlines, protocols, , Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, Submission Data File specifications, other key-study related documentation, protocol deviations, Data Quality Review, and Clinical Study Reports (CSRs).
  • Be familiar with statistical policy and strategy at the company.
  • Stay abreast of latest developments in the field of statistics in drug development.

Qualifications and Skills Required:
  • PhD in statistics or related field and at least 6 years of industry experience or MS in statistics or related field and at least 10 years of industry experience
  • Comprehensive knowledge of clinical trials methodology, regulatory requirements, HEOR, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically
  • Proficient in Microsoft Office
  • Professional, proactive demeanor
  • Excellent written and verbal communication skills
  • Experience with people management and development of staff
  • Excellent interpersonal and project management skills
  • Able to collaborate effectively with internal and external study management teams to meet project timelines
  • Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results

Pay Rate  between $90 - 103/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

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