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>
>Director, Biostatistics
>
>Job Description:
>
> * Oversee Biostatistical functions and responsibilities for
> * Involving study design, statistical plan and sample size
> determination and overall project plan.
> * Preparing statistical analysis plans.
> * Conducting statistical analyses and prepare statistical summary
> tables.
> * Coordinating with data managers on the CRF and database designs.
> * Working closely with SAS programmers on the derived datasets and
> review of safety tables.
> * Providing the statistical components of eCTD.
> * Interfacing with regulatory agencies and IRB on ad hoc protocol
> and eCTD inquires.
> * Monitor and Oversee statistical analysis plans, analysis results and
> statistical tables performed by CROs and DSMB consulting statistician.
> * Participate in the Project Team Meeting and coordinate with clinical
> and regulatory staff on timelines and statistical issues.
> * Advise head of Biostatistics and Data Management on budget, resource
> and data management policy issues.
> * Recruit and Supervise junior biostatisticians.
> * Responsible for the creation of biostatistical SOPs and review of
> new regulatory guidelines on statistical related issues.
>
>Qualification:
>
> * Ph.D. in statistics or biostatistics.
> * Over seven years experience in clinical research preferred, some
> with pharmaceutical or biotechnology companies.
> * Proficiency in SAS programming.
> * Experience in NDA and eCTD preparation.
> * Supervisory experience highly desirable.
>
>
>Idenix offers an excellent benefits package including competitive salary,
>equity compensation, major medical insurance, dental insurance, 401(k)
>plan participation, and group life and disability insurance.
>
>To be considered for this position, please send your resume by email to
><mailto:[log in to unmask]>[log in to unmask], or by mail to:
>Human Resources
>Idenix Pharmaceuticals
>60 Hampshire Street
>Cambridge, MA 02139
>
>
>Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the
>discovery, development and commercialization of new treatments for
>life-threatening infectious diseases. Idenix has a deep pipeline of
>candidates which are currently in or soon to be entering clinical trials
>for the treatment of Hepatitis B, Hepatitis C and HIV. Idenix's lead
>compound telbivudine for the treatment of Hepatitis B virus (HBV) is
>currently being evaluated in a late phase clinical trial with over 1350
>patients.
>
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