Strategic Biostatistics Director
Providestrategic biostatistical input to internal and external clients in drug,biologic, or device development areas with an emphasis on clinical trialdesign, interim decision making, and analysis using novel and advancedstatistical methods.
- Providestrategic biostatistical input at the study level to internal and externalclients which ensure the optimal clinical trial design will be implemented.
- Support thedevelopment of efficient CDPs for external clients by incorporating innovativestatistical methods to meet the goals and objectives of their development program
- Represent clientsat meetings with FDA or European regulatory authorities to defend protocoldesigns or analyses.
- Contributeto the biostatistical component of Due Diligence (DD) assessments of compoundsfor small or moderate value opportunities for which investment is beingconsidered, and provide strategic biostatistical support on individual studiesin cases where investment has already been made.
- Maintainknowledge and awareness of developments in biostatistics, clinical trialmethodology, and regulatory requirements that impact on design or analyses formultiple therapeutic areas. May carry out new developments in areas ofstatistical design or analysis that can be benefited by clients and used togive Quintiles a greater edge over competing CROs.
- MarketQuintiles strategic biostatistical expertise, may include:(i) publishing papersthat demonstrate strategic bios expertise in key areas (such as adaptive design,multiple comparisons, Bayesian analysis, etc.); (ii) giving presentations atconferences, particularly those attended by key decision makers for outsourcinghigh value business; (iii) and publicizing internally to key groups.
- Participatein the provision of training to internal and external clients on advancedstatistical topics or advanced case studies.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Goodknowledge of innovative and complex statistical analysis methods that apply toclinical trials, which can be used to cut time, cut costs, and/or increasechance of success;
- Goodknowledge of the new and cutting-edge design approaches (including some typesof adaptive designs) that can beneficially be applied to clinical trials;
- Ability todevelop new statistical methods and strategies;
- Goodknowledge of current FDA or EMEA regulatory requirements with respect to studydesigns, primary endpoints, and acceptable analyses for two or more therapeuticareas;
- Goodunderstanding of the complete clinical drug development process;
- High levelknowledge of SAS and R;
- Excellentwritten and oral communication skills
- Ability toestablish and maintain effective working relationships with coworkers, managersand clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- PhD oreducational equivalent in biostatistics or related field and 10 years relevantexperience; or Master’s degree or educational equivalent in biostatistics orrelated field and 15 years relevant experience; or equivalent combination of education,training and experience.
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