Statistical Analyst & Programmer

Statistical Analyst & Programmer

Keyrus Group

Walloon Brabant, Belgium

Job Description

Keyrus Life Science is looking for a Statistical Analyst & Programmer to join our consulting team for a client project based in Walloon Brabant, Belgium. This person will be responsible of the provision of Services in support of Nonclinical or Clinical Statistical services.

This may include (but is not limited to) any of the following:

• Participate in study preparation (eCRF, and DMP (iDRP and Domain datasets and individual listings) review),
• Participate in study SAS datasets structure (environmental tables) review,
• Develop the Tables, Figures and Listings (TFL) or Table Of Content (TOC) for clinical/Epi studies or assays
• Write technical specifications for elimination codes and protocol deviations
• Develop, maintain and document elimination codes and protocol deviations programs
• Write specifications for SAS/R/JMP programs/macros for analyses Datasets (project, study and/or standard),
• Develop, maintain and document SAS/R/JMP programs/macros for study specific analyses (Datasets and analysis)
• Validate (peer review) and document SAS/R/JMP programs/macros for study specific analyses (Datasets and analysis) and elimination codes and protocol deviations programs
• Periodic run and consolidation of elimination codes and protocol deviations
• Pre-Database Freeze cleaning checks on RAW data
• Creation of annexes of Stat report (SR tables, CTRS tables, XML files, …)
• Provide input on additional analysis request
• Perform Database Documentation for study specific analyses or at the standard level
• Review and ensure adherence to standards at the study or standard level,
• Support quality control (L1 QCs) and quality audit of deliverables,
• Develop, maintain and validate SAS programs for across-projects activities (PLDS, DSUR/PBRER, Web-Disclosure, eSubmission, iDAC)
• Develop, maintain and validate SAS standard macros for core standard activities
• Provide input into workload, technical and process initiatives
• Uses stat methodology to establish study strategy (e.g. Power modeling of different scenario, set-up power monitoring, set-up mitigation plan to minimize risk of stat failure)
• Provides input to the concept protocol and protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)

Profile

• Minimum 2 years of experience as statistical analyst/statistical programmer in product development within the pharmaceutical industry.
• Hands-on experience with SAS & R.
• CDISC knowledge: ADAM & TFL.
• Master in Statistics or related areas.
• Experience in multidisciplinary projects.
• Fluent English is required, French is a plus.
• Good communication and teaching skills.

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