Theorem Clinical Research India Private Limited -Senior Statistician / Statistician : Clinical Trials / Biometrics-k

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Careers Save this Job Report this job Theorem has a strong focus on regulatory affairs in addition to its clinical research activity. In the newer markets, Omnicare has ensured that Omnicare selects employees with not only clinical research experience, but significant experience in managing all the regulatory aspects of the study. The breadth of experience and expertise this brings to clients is particularly important in early phase, developmental work as the staff have a strong understanding of the requirements of regulatory agencies when considering data and facilitating approvals. Omnicare now has a wholly owned subsidiary in India, located in the Bangalore. Bangalore is centrally located with proximity to most major centres for clinical research and provides communications and IT infrastructure hub for India. Together, these facilitate communication and an ability to manage clinical sites. The Indian operation will concentrate on the conduct of global & local clinical programmes and will report administratively to the appropriate senior management. The Operations Manager, India will be responsible for facilitating communications with investigators and with the regulatory bodies, and ensuring that all study start activities including approvals for conduct of the study, importation of study drugs and transport of biological samples are expedited. Omnicare has been managing and conducting clinical trials in India since 1996. Over the years Omnicare has observed the growth of our customers interest in India as a site for global clinical trials and also the significant changes in the regulations relating to the conduct of studies in this country, which now facilitate the inclusion of India in multi-country studies. In recent years Omnicare has conducted studies in infectious disease, paediatric ophthalmology, oncology and CNS disorders, as well as assessing opportunities in diabetes, cardiovascular disease and oncology. Designation Senior Statistician / Statistician : Clinical Trials / Biometrics Job Description - Conduct basic and assist with complex statistical analysis in support of clinical research studies as specified in statistical analysis plans, including statistical graphics. - Verify randomization codes for a basic study design and develop randomization specifications for basic and complex study designs. - Prepare statistical sections of protocols (including sample size determinations)and statistical analysis plans. - Prepare and annotate safety and basic and complex efficacy shell data displays. - Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets. - Perform and quality control of data displays that show basic and complex inferential statistics. - Perform quality control of safety and efficacy analysis datasets. - Maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication (internal and client). - Maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory, and that all interim programs and output are deleted at the completion of the project. - Handle miscellaneous tasks as assigned by management. - Able to review case report (CRF)design, data management plan, and edit specifications for a clinical trial. - Able to review clinical study report (CSR)for staistical concerns. - Able to provide input to standard operating procedures (SOP)and audits. - Able to mentor new hire statisticians. - Able to propose solutions to problems that arise while proforming tasks. - Perform quality control of datasets and data displays for integrated summary of safety and efficacy. - Produce quality deliverable within timelines and with customer satisfaction. - Develop effective time management skills. Desired Profile Statistician who should be able to analyze all parts of a single clinical project and provide basic planning for similar protocols. Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate safety and basic and complex efficacy shell data displays. Conduct all statistical analyses in support of clinical research studies.Statistician  with experience in SAS Programming Experience 2 - 7 Years Industry Type Pharma / Biotech / Clinical Research Role Bio-Statistician Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology Education UG - Any Graduate - Any Specialization PG - Any Postgraduate - Any Specialization, Post Graduation Not Required DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required Location Bengaluru/Bangalore Keywords Statistician Biometrics Clinical Research Pharma and Biotech and Clinical ResearchBiostatistics Statistical Programming Statistical Modeling Statistical Simulation / Regression ModelingPharma and Clinical Research Contact Ms. Bhagya Theorem Clinical Research India Private Limited Email sunil.chandran@theoremclinical.com Website https://www.TheoremClinical.com Job Posted 17 Sep Reference SESTST Save this Job Report this job