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 @ Jeeva@takesolutions.com, Ph.: 609-720-1002 x 9325
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