Bio Statistician
Bio Statistician
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Job Description
General information
Publication date
11/03/2024Category
OPERATIONS - CONSULTING
Job title
Bio Statistician
Contract
Permanent contract
Job description
JOB DESCRIPTION :
Description of tasks and responsibilities in each field
Provide statistical input to the design analysis and interpretation of results from clinical studies and development plans in close interaction with different stakeholders (e.g. clinical representatives safety team data management team)
Write and review key clinical and statistical documents (e.g. Protocol Statistical Analysis Plan SAP Data Management Plan DMP Prescription Drug Monitoring Program PDMP Case Report Form CRF Clinical Study Report CSR)
Provide high-quality and timely statistical analyses results to support correct and timely decision-making
Act as a statistical representative within cross-functional study teams and project sub-teams and provide statistical support and
solutions
Provide statistical support for briefing books submissions health authorities requests publications and other relevant documents
Support interactions with health authorities
Provide input to internal process improvements and/or new statistic capabilities
Maintain current scientific and regulatory knowledge
Competencies required for support level :
Msc. or PhD in Statistics or related field
At least 8 years of experience as a statistician in the pharmaceutical industry
Proficient in English (oral and written)
Good programming skills in SAS (Macro SQL) and R (function package)
Strong statistical methodology knowledge applied to non-clinical/pre-clinical/clinical projects
Able to propose and implement new statisticial methodologies
Excellent knowledge of GCP and ICH guidelines
Excellent communication skills able to build good relationships with internal and external stakeholders able to explain advanced
statistical concepts in terms understandable to non-statisticians
Leadership able to lead a statistical and a programming team
Able to manage drive and meet delivery timelines
Team player able to work in multidisciplinary teams
Excellent knowledge of regulatory requirements related to statistics (e.g. ICH E9/E10)
Technical knowledge of CDISC standards (ADaM SDTM)
Strong experience in submission and interaction with health authorities.
Business Industry
Life sciences
Profile
As a Clinical Statistician you provide expert statistical input and contribute to development plans design protocol writing statistical analysis and interpretation of results from clinical studies. You are accountable for the timely availability of high-quality analysis results to support provide statistical oversight
and guidance to teams and outsourcing partners.
Job location
Asia Pacific India Karnataka Bangalore
Location
Candidate criteria
Level of experience
5 to 10 years
Employment Type
Full-Time
