Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies.
Post : Assistant Manager
Job Description
- Read and understand the study protocol, statistical analysis plan and CRF.
- Understand BA/BE studies and able to develop datasets and TLGs.
- Preparing of tables, listing and graphs, as applicable.
- Creation of ADaM dataset specification and ADaM dataset or non-standard dataset.
- Design, develop and maintain programs that will produce and/or validate safety and efficacy tables, listings and figures.
- Participate in establishing the programming scope for a deliverable with study statistician and study team and ensure high quality results and milestones are achieved efficiently.
- Creation of macros and use existing macros to generate reports.
- Responsible to ensure that all output within a project is accurate and has consistent appearance.
- Work on multiple projects simultaneously and meet the timeline.
- Training/Guiding/Mentoring associate programmer and junior programmers.
- Job allocation & distribution to associate programmers and junior programmers and evaluation of the progress of the project
- Facing client to answer technical queries
- Performance evaluation
- Any other responsibilities assigned by the organization from time to time
Candidate Profile
• SAS programming experience across clinical domains in the Pharmaceutical industry.
• Good knowledge in all phases of clinical trials.
• Exposure in working in different therapeutic areas like Oncology, etc.
• Familiar with CDISC conventions, i.e.SDTM and ADaM models and hands on experience in implementing these models.
• Ability to work independently.
• Excellent communication skills.
Additional Information
Qualification : M.Pharm, M.Sc
Location : India
Industry Type : Pharma
End Date : 25th July, 2018
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