Require Manager with statistical experience at Syngene International
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 : Manager
Read and understand the study protocol, statistical analysis plan and CRF.
• 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.
• Manager performance review for the team
• Mentoring and coaching team members and plan for their development.
• Resource planning and allocation
• Client management and process improvement
- Statistical experience in Clinical Trials and BA/BE studies.
- SAS Programming experience in Clinical domain in the Pharmaceutical industry.
- Exposure in working in different therapeutic areas like Oncology etc.
- Familiar with CDISC conventions, i. e SDTM, ADAM models and hands on experience in implementing these models.
- Ability to work independently.
- Excellent communication skills.
- Experience in handling team.
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Statistical analysis
Job ID: 2503
End Date: 25th March, 2018
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