Bio Statistician
- Akkodis
- 5 - 10 years
- Bengaluru
- 2 years ago
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Job Description
- Provide statistical input to the design, analysis and interpretation of results from clinical studies, and development plans in close interaction with different stakeholders (eg, clinical representatives, safety team, data management team)
- Write and review key clinical and statistical documents (eg, 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 (eg, ICH E9/E10)
- Technical knowledge of CDISC standards (ADaM, SDTM)
- Strong experience in submission and interaction with health authorities.
-
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 decision-making
- You provide statistical oversight and guidance to teams and outsourcing partners
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Data Science & AnalyticsRole Category: Data Science & Machine LearningRole: StatisticianEmployement Type: Full timeContact Details:
Company: AkkodisLocation(s): Bengaluru
Keyskills: C++ SAP Data management SAS GCP Consulting Life sciences Automotive Monitoring SQL
Akkodis
Akkodis is a global digital engineering company and Smart Industry leader. We enable clients to advance in their digital transformation with Talent, Academy, Consulting, and Solutions services. Our 50,000 experts combine best-in-class technologies, RD, and deep sector know-how for purposeful innovat...
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