- 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.
- 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 statistical 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
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Biostatistician - Bengaluru, India - Akkodis
Description
JOB DESCRIPTION:
Experience Level: 5+ years only
Brief description of the job
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 timely availability of high-quality analysis results to support decision making. You provide statistical oversight and guidance to teams and outsourcing partners.
Description of tasks and responsibilities in each field
Competencies required for support level:
