Thermo Fisher Scientific – Principal Statistical Scientist.

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Full-time

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Job Description

  • We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
  • This is a position within our Statistical Science pillar, a specialist group that provides expert knowledge of advanced statistical methods and applications within the Biostatistics and Programming department, to other departments and to our clients.

As a Principal Statistical Scientist, you will:

  • Perform a statistical consulting role both internally and externally.
  • Serve as the lead statistician on broad-based projects or complex, multiple protocol programs as required.
  • Serve as the scientific and therapeutic area thought leader for study design and statistical analysis issues.
  • Provide scientific strategy consultation to clients for drug or device development planning.
  • Provide statistical input into corporate initiatives.
  • Maintain expertise in state-of-the-art data manipulations and statistical analyses.
  • Represent the department to clients on complex study scientific and design considerations, directly contributing to complex study proposals and bids, representing the department at bid defenses.

Essential Functions:

  • Provides expert knowledge within the department on statistical and regulatory issues, mentoring members of the department and providing project guidance and statistical advice.
  • Serves as a lead statistician on high complexity statistical projects and for consulting projects.
  • Provides expert knowledge and experience to project teams on complex and novel statistical methodology across different therapeutic areas.
  • Provides statistical support to global corporate initiatives and supports/leads departmental efforts on working groups.
  • Provides expertise and leads the development and delivery of technical training for the department and the company.
  • Provides input into study design and sample size calculations during protocol development, writes or reviews statistical analysis plans and performs or validates statistical analyses.
  • Provides senior review on projects.
  • Provides input to management as to hiring recommendations, department policies, and resourcing requirements.
  • Assists in bidding, proposal development and other business development activities, as required.

Education and Experience:

  • Master’s degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and 5+ years of clinical trial experience as a statistician;
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’).

OR

  • PhD. in statistics, biostatistics, or equivalent field with appropriate statistical coursework and 3+ years of clinical trial experience as a statistician

Knowledge, Skills and Abilities:

  • Demonstrated initiative and motivation
  • Excellent verbal and written communication skills, including proficiency in the English language
  • Positive attitude and the ability to work well with others in a multi-disciplinary setting
  • Excellent understanding of SAS® and clinical biostatistics
  • Demonstrated understanding of the drug development process
  • Conversant knowledge of FDA and other regulatory guidances and regulations
  • Capable of managing change and uncertainty to optimize positive outcomes
  • Excellent project management skills, including leadership of complex projects
  • Excellent organizational skills with the ability to adapt and adjust to changing priorities
  • Strong theoretical background and applied statistical knowledge
  • Capable of mentoring with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic are
  • Capable of communicating complex statistical concepts in a multi-disciplinary setting
  • Demonstrated knowledge in one or more therapeutic areas.

To apply

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