Hello Associates,


We currently have a *6 Months Contract* opportunity for a *Biostatistician*
with our direct client located in *Berkeley Heights, NJ.*



*Responsibilities will include, but are not limited to, the following: *

·         Work under the direction of Medical Affairs Statistics Disease
Lead

·         Actively provide statistical support to the Medical Affairs
Department

·         Provide statistical support for publications, presentations,
posters for medical meetings and any other requests not covered in the
clinical study report. This includes data mining, meta-analysis, and
support for data-driven analyses.

·         Interact with authors, referees and in-house reviewers in the
preparation of publications, presentation and posters as needed.

·         Provide statistical reviews of proposed design and analysis of
protocols for investigator initiated trials.

·         Provide statistical input for design, sample size,protocol, and
CRF for Medical Affairs studies.

·         Provide review of statistical analysis plan including table
shells, analysis dataset specifications and all deliverables for Medical
Affairs studies provided by CRO

·         Manage outside CROs and consultants as needed.

·         Work closely with different departments in the company
(regulatory, clinical, marketing, data management, health economics, etc.)
and provide statistical support for a variety of functional groups.



*Skills/Knowledge Required: *

·         Masters or PhD in Statistics with a focus on statistical methods
appropriate for clinical trials is essential.

·         3-5 years of experience and demonstrated skill in the planning,
analysis and reporting of clinical trials.

·         Experience in oncology trials a plus

·         Good planning and project management skills.

·         Detailed knowledge of currently accepted statistical
methodologies.

·         Excellent SAS skills including report generation. Willingness to
be hands-on when needed.

·         Knowledge of MS Office products (Word, Excel, PowerPoint)

·         Excellent communication, writing and organizational skills is
essential.

·         Demonstrated ability to work in a team environment with
clinicians, clinical monitors, data managers, programmers and medical
writers.



Please reach me for further  details  @ je...@takesolutions.com, Ph.:
609-720-1002
x 9325

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