Provide strategic biostatistical input to internal and external clients in drug, biologic, or device development areas with an emphasis on clinical trial design, interim decision making, and analysis using novel and advanced statistical methods.
•Provide strategic biostatistical input at the study level to internal and external clients which ensure the optimal clinical trial design will be implemented.
•Support the development of efficient CDPs for external clients by incorporating innovative statistical methods to meet the goals and objectives of their development program
•Represent clients at meetings with FDA or European regulatory authorities to defend protocol designs or analyses.
•Contribute to the biostatistical component of Due Diligence (DD) assessments of compounds for small or moderate value opportunities for which investment is being considered, and provide strategic biostatistical support on individual studies in cases where investment has already been made.
•Maintain knowledge and awareness of developments in biostatistics, clinical trial methodology, and regulatory requirements that impact on design or analyses for multiple therapeutic areas. May carry out new developments in areas of statistical design or analysis that can be benefited by clients and used to give Quintiles a greater edge over competing CROs.
•Market Quintiles strategic biostatistical expertise, may include:(i) publishing papers that demonstrate strategic bios expertise in key areas (such as adaptive design, multiple comparisons, Bayesian analysis, etc.); (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business; (iii) and publicizing internally to key groups.
•Participate in the provision of training to internal and external clients on advanced statistical topics or advanced case studies.
Qualifications & Requirements
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
•Good knowledge of innovative and complex statistical analysis methods that apply to clinical trials, which can be used to cut time, cut costs, and/or increase chance of success;
•Good knowledge of the new and cutting-edge design approaches (including some types of adaptive designs) that can beneficially be applied to clinical trials;
•Ability to develop new statistical methods and strategies;
•Good knowledge of current FDA or EMEA regulatory requirements with respect to study designs, primary endpoints, and acceptable analyses for two or more therapeutic areas;
•Good understanding of the complete clinical drug development process;
•High level knowledge of SAS and R;
•Excellent written and oral communication skills
•Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
•PhD or educational equivalent in biostatistics or related field and 10 years relevant experience; or Master’s degree or educational equivalent in biostatistics or related field and 15 years relevant experience; or equivalent combination of education, training and experience.