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Job Id
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2521655
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Title
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Sr. Biostatistician
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Job Type
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Permanent
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Duration
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City
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Hyderabad
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State
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Telangana
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Zip
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500081
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Job Description
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MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
www.makrocare.com
JOB ROLES AND RESPONSIBILITIES:
Preparation and Review of Statistical Analysis Plan (SAP)
Preparation and Review of Mock Tables, Listings and Figures (TLFs)
Preparation and Review of Statistical Analysis Report (SAR)
Involve in statistical review of final deliverables to the client
Involve in planning and design of the study
Preparation and Review of inputs for the protocol development including sample size calculation and randomization
Preparation and Review of Biostat quote preparation for proposed studies
Review of Case Report Form (CRF)
Preparation of critical data points for CDM team
Preparation and Review of programming specifications for Analysis datasets creation
Review of Clinical Study Report (CSR)
Any other responsibilities assigned by the Director - Biostatistics as and when need arises.
Maintain 100% Quality and on time delivery of above activities
KEY RESULT AREAS:
Acquire up to date information about statistical software updates and knowledge of statistical methods and techniques in SAS programming. Get trained in current data standards, templates and guidelines in regulatory submissions. Periodically updating CDISC skills through guidelines. It is expected that the post holder will perform duties without direct supervision and will be self directed in terms of time and workload management.
PROFESSIONAL:
Good knowledge in statistical concepts, methodology and SAS programming.
Minimum 6 years experience in a pharma / CRO is essential
LEADERSHIP AND MANAGEMENT:
Strong interpersonal and communication skills
Expertise in strong database management skills and computer applications
Strong writing skills
Ready to work in a team
Take lead role to complete the statistical activities including SAS programming for the assigned studies.
EDUCATION:
Masters degree in Statistics / Biostatistics is essential
Knowledge in SAS programming is desirable.
Research :
Interest in statistical methods, clinical research, drug development and CDISC activities.
Strong desire to learn new techniques in SAS and statistics
EQUIPMENT & MACHINERY:
Post holder is expected to have knowledge and ability to use all equipment used in the area, however, may not have daily clinical involvement.
ASSIGNMENT AND REVIEW OF WORK:
The Sr. Statistical Analyst / Sr. Bio statistician is an important member of the Bio-metrics Department and is responsible for preparation of inputs for the protocol development, sample size estimation, randomization plan, Statistical Analysis Plan including mock TLFs and Statistical Analysis Report. Review will be done quarterly by Director - Bio statistics, mainly pertaining to quality of work, timelines met and volume of projects handled. Other review areas will be assisting colleagues, initiative in tasks, soft skills, attitude, team guidance and team building activities, etc.
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Qualification
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Masters Statistic or Biostats
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Certification/Licensure
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Experience
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6
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Job Category
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Biostatistician
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Posted On
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9/24/2019
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Expires On
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10/24/2019
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