- 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 5 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
- Good knowledge of GCP and ICH guidelines
- Advanced 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
- Advanced knowledge of regulatory requirements related to statistics (e.g., ICH E9/E10)
- Technical knowledge of CDISC standards (ADaM, SDTM)
Clinical Statistical Programmer - Dubai, United Arab Emirates - Akkodis
Description
Akkodis, a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation.
With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market, and shape a smarter and more sustainable tomorrow.
As part of our growth in the region and our portfolio development, we are looking for a Clinical Statistician
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 (Senior)