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Showing posts with label Biostats. Show all posts
Showing posts with label Biostats. Show all posts

Wednesday, 26 October 2016

GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post : Biostatistician

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Job description 
- participate in the clinical/epidemiological development plan (trial designs, sample sizes, interim analysis, etc.) in collaboration with clinical development managers, safety physicians, clinicians and epidemiologists. In particular, provide statistical, and scientific input into clinical development planning
- be responsible for the statistical designs of clinical/epidemiological studies, creating statistical sections for study synopses and protocols
- input in study set up (case report forms, database, randomization)
- explore new statistical approaches and methodologies through innovative and creative thinking
- propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
- write and execute SAS programs to analyze the data and to report results creating tables and standard listings
- perform statistical analysis, run simulations and discuss with internal and external experts
- support scientific writers and clinicians to correctly interpret the statistical results and align them with the clinical report conclusions
- write the statistical sections of clinical study reports, statistical publications and prepare materials for publications and create statistical text for clinical study communications
- input in standard processes (review of Standard Operating Procedures, guidelines, definition of new processes needed)




Wednesday, 5 October 2016

Job Description


-Performs biostatistical and programming activities for given clinical trials involving drugs, biologics and medical devices.
-Responsible for all statistical tasks with a high level of independence e.g. clinical trial design/planning, sample size estimations, analysis plan, defining safety, efficacy and exploratory endpoints, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase .
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Within the context of biological product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices.
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Able to manage CRO deliverables.
- Follow processes and adhere to Health Authority requirements (SOP's, GCP and regulatory guidelines).Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Trial Teams

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