Achieva Group Ltd

Senior Statistical Programmer

CHF £104/Hour
15 Jan 2021
14 Feb 2021
Full Time
Contract Type
Experience Level
Senior Management

Job Responsibilities:

• Responsible for the implementation and use of programs to effectively analyze and report clinical trial data as the trial lead programmer

• Responsible for the review of trial documentation and providing feedback from statistical programming perspective, as well as study set-up in the reporting environment

• Responsible for the definition of project and trial analysis data sets and metadata

• In agreement with the lead statistical programmer and/or statistician, designs and implements trial and project analysis data sets and metadata including complex data derivations, data mapping and data pooling

• Manage critical issues within the project by pro-actively suggesting solutions to the lead statistical programmer and/or statistician

• Develops programs and generates tables, listings and figures for trial or project specific

reports and statistical analyses in agreement with trial documentation and guidelines from the principal statistical programmer and/or the statistician

• Performs and documents quality control (QC) activities as per Idorsia standard operating procedures (SOPs), working practices, and guidance from the lead statistical programmer.


Candidate’s Requirements:

• University degree (or equivalent) preferably in mathematics, informatics or other scientific discipline

• Advanced knowledge of programming in SAS and of statistical analyses in clinical trials

• Min of 5 years’ experience in statistical programming within a pharmaceutical company or a clinical research organization (CRO)

• Experience in the review of Statistical Analysis Plans, study set-up and review of study

specific documents, e.g. Clinical Protocol, CRF, annotated CRF, data validation guidelines

• Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management

• Good knowledge and understanding of CDISC, especially SDTM and ADaM

• Basic knowledge of R, knowledge of other programming languages and of data management principles and tools is an asset

• Proven record to work independently, analyze problems and formulate ideas in a structured and logical manner

• Knowledge of international clinical research regulations and requirements (ICH-GCP)

• Excellent interpersonal and communication