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US: Dir, Biostatistics

Date: 08-Jan-2016
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Dir, Biostatistics

RESPONSIBILITIES

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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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/