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• Technical responsibilities:
i) Serve as a statistical consultant for other members of the ASA and clients;
ii) Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact design and analyses;
iii) Represent clients at meetings with regulatory agencies or other regulatory meetings; may participate as a member of a Data and Safety Monitoring Committee;
iv) As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication;
v) Will participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, writing sections of joint clinical/statistical reports, performing modeling and simulations, running analyses.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
• Good knowledge of most standard and complex statistical design and analysis methods or/and commercial analytics (e.g., marketing science, health economics) that apply to Phase I-IV or post-marketing clinical trials and assessment.
• In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• High level of knowledge of current FDA and EMA regulatory requirements with respect to clinical development programs, study designs, primary endpoints, and acceptable analyses for multiple therapeutic areas.
• Demonstrated ability to develop new (design and analysis) methods or tools to provide benefits to clients (e.g., reduce costs, decrease time of drug development)
• Comprehensive understanding of the clinical drug development process.
• Knowledge of SAS, R, and other advanced statistical software as needed
• Excellent written and oral communication skills with excellent interpersonal skills
• Ability to operate simultaneously across numerous projects, for many of which the ability to operate in a SWAT type mode is required
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Very strong negotiating skills
• Excellent problem solving skills
• Excellent presentation skills
• Excellent judgment/decision making
• Leadership and line management skills
• Some demonstrated success of operation within senior/executive management teams
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• PhD or educational equivalent in biostatistics or related field and 7 years of relevant experience including 4 years of management experience; or Master degree or educational equivalent in biostatistics or related field and 10 years relevant experience including 4 years of management experience; or equivalent combination of education, training and experience
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