US: Dir, Biostatistics
To apply for this position, please visit this Website. http://biotech.fyicenter.com/jobs/99886451_Dir__Biostatistics.html
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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BioTech FYI Center
http://biotech.fyicenter.com/

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