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- 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.
- 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’).
- 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.