Study Lead Statistician Specialist

3 days ago


Thousand Oaks, California, United States Volt Full time
Job Summary

As a Study Lead Statistician at Volt, you will play a key role in providing statistical support for multiple clinical studies across all phases of clinical development. You will apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.

We are seeking an experienced Study Lead Statistician who can work collaboratively with our team to deliver high-quality results. The successful candidate will have a strong background in statistics and clinical trials methodology, as well as excellent communication and project management skills.

The primary responsibilities of this role include:
  • Performing all duties and responsibilities associated with the Study Lead Statistician position
  • Attending Clinical Study Team meetings and providing all required statistical input related to strategy and operations of the clinical study
  • Planning and executing 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)


Additionally, we are looking for a candidate who is familiar with statistical policy and strategy at the client, stays abreast of latest developments in the field of statistics in drug development, and has excellent written and verbal communication skills.

Requirements

To be successful in this role, you will need to possess the following qualifications and skills:
  • 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


About the Company

Volt is a leading provider of technology and business transformation solutions. We employ approximately 50,000 professionals worldwide and report an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

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