Require Manager with statistical experience at Syngene International

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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

Job Description:
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

Required Skills:

  1. Statistical experience in Clinical Trials and BA/BE studies.
  2. SAS Programming experience in Clinical domain in the Pharmaceutical industry.
  3. Exposure in working in different therapeutic areas like Oncology etc.
  4. Familiar with CDISC conventions, i. e SDTM, ADAM models and hands on experience in implementing these models.
  5. Ability to work independently.
  6. Excellent communication skills.
  7. Experience in handling team.

Additional Information:
Location: India
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: S
tatistical analysis
Job ID: 2503
End Date: 25th March, 2018

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