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Specialist - Biostatistics print Print

Company Name: Dr Reddys Labs
Location: Hyderabad
Experience: 3 - 9 year(s)
Annual Salary: INR 1800000 - 1800000
Disability Accepted: Hearing Impairments (Hard of Hearing), Hearing Impairments (Total Deafness), Hearing and Speach Impairments, Intellectual Disabilities, Learning Disabilities, Locomotor Impairments, Mental Illness, Speech Impairments, Visual Impairments (Low Vision), Visual Impairments (Total Vision Loss), Developmental Disabilities
Vacancies: 1
Posted by : Fanny Mercy , 300 days ago

Job Description

Industry: Pharmaceuticals
Functional Area: Pharmaceuticals
Job Role : Specialist - Biostatistics
Job Description: Statistical Design
Suggest which type of design should be used for Phase I to Phase IV clinical studies based upon previous literature results in accordance with Regulatory guidelines
IN ORDER TO have a practically applicable design

Sample Size
Provide the appropriate Statistical Methods to find the Sample size for Phase I to Phase IV clinical trials
IN ORDER TO achieve adequate power of the study.

Statistical Analysis Plan and execution
To Draft & Create Statistical Analysis Plan which include the Statistical Methods to be used, Draft and Create Tables, Listings & Graphs and provide Statistical analysis outputs using SAS
IN ORDER TO file complete statistical Study Report to different regulatory agencies

Knowledge sharing of new statistical tools
Build and share knowledge of new Statistical Methods (e.g. New Designs used in Clinical trials, Interim Analysis, Event analysis etc.)
IN ORDER TO demonstrate their usefulness to the scientific community.

Deficiency Response
Respond to Statistical queries from regulatory agencies on submitted clinical studies. Review the clinical studies report
IN ORDER TO ensure that Statistical Methods and analysis are correctly implemented

Statistical support in Stability Analysis, POP BE and
"Present statistical methods on Stability Data, PSD Data and in-vitro BE data and analyse data provided by various teams
IN ORDER TO effectively use available statistical support in house "
Statistical support for CDISC
"Statistical Support for Creation CDISC Data sets and review the CDISC data sets
IN ORDER TO provide CDISC compliant study reports for regulatory submissions "

Desired Candidate Profile

Key Skills: Understanding of Statistical methods in Clinical Research, Phase I to Phase IV clinical trials, CDISC, GCP/GLP, Pharmacokinetics, SAS Promgramming, Interpersonal Skills, Presentation Skills & Good Analytical Skills
Qualification: M.Sc
Candidate Profile: Masters in Statistics with 3-9 years experience in handling statistical part of Clinical Trials, proficiency of SAS Programming.

Knowledge on: Statistics, Bioequivalence Study, Clinical Trials and SAS Programming in Pharmaceutical Industry.

Behavioral Skills: Interpersonal Skills, Presentation Skills & Good Analytical Skills

Company Profile

Company: Dr Reddys Labs
Company Description: Refer company website

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