Principal Statistical Scientist at Thermo Fisher Scientific

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