Kennziffer der Stelle
Operations — Engineering
1 bis 3 Jahre
AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.
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.
What are your responsibilities ?
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
What skills do you bring to the table ?
Msc. or PhD in Statistics or related field
At least 2 years of experience as a statistician in the pharmaceutical industry
Proficient in English (oral and written)
Good programming skills in SAS (Macro, Structured Query Language [SQL]) and R (function,
Strong statistical methodology knowledge applied to non-clinical/pre-clinical/clinical projects
Good knowledge of Good Clinical Practice [GCP] and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH] guidelines
Good communication skills, able to build good relationships with internal and external stakeholders, able to explain advanced statistical concepts in terms understandable to non-statisticians
Able to manage, drive and meet delivery timelines
Team player, able to work in multidisciplinary teams
Knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10)
Technical knowledge of Clinical Data Interchange Standards Consortium [CDISC] standards (ADaM, Study Data Tabulation Model [SDTM])
What’s the offer you can’t refuse?
As an Akkodis Team Member, you will be:
• Onboarded in your position via a buddy process
• Supported in your career by your Business Manager
• Actor of your training plan and your personal and professional development
• Benefiting from a permanent contract
• Benefiting from a competitive salary package including several extra-legal benefits
Do you any questions? You can contact me at email@example.com
Diese Stellen könnten Sie interessieren
Ingénieur FPGA H/F
OPERATIONS — Engineering
Software Engineer Frontend
OPERATIONS — Engineering
Provincia di Latina