Strategic Biostatistics Director|
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
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.
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.
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.
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.
Qualifications & Requirements
in the provision of training to internal and external clients on advanced
statistical topics or advanced case studies.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
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;
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;
knowledge of current FDA or EMEA regulatory requirements with respect to study
designs, primary endpoints, and acceptable analyses for two or more therapeutic
understanding of the complete clinical drug development process;
• High level
knowledge of SAS and R;
written and oral communication skills
• Ability to
establish and maintain effective working relationships with coworkers, managers
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.