Principal Statistical Scientist at Thermo Fisher Scientific

Summarized Purpose:

Performs a statistical consulting role both internally and externally. Serves as the lead statistician on broad-based projects or complex, multiple protocol programs as required. Serves as the scientific and therapeutic area thought leader for study design and statistical analysis issues. Provides scientific strategy consultation to clients for drug or device development planning. Provides statistical input into corporate initiatives. Maintains expertise in state-of-the-art data manipulations and statistical analyses. Represents 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. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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