Clinical Statistician

Job description

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

Profile

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,
package)
 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 aswah.fawad@akkodis.com