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
Apply via :
jobs.thermofisher.com
