Job Description
Senior Statistical Programmer
We are seeking an experienced Senior Statistical Programmer to join our team. The successful candidate will be responsible for implementing and using programs to effectively analyze and report clinical trial data.
Main Responsibilities
* Implementation and use of programs to analyze and report clinical trial data
* Review of trial documentation and provision of feedback from a statistical programming perspective
* Information and suggestion of solutions to critical issues within the project
* Development of programs and generation of tables, listings, and figures for trial or project-specific reports and statistical analyses
* Performance and documentation of quality control activities as per company standard operating procedures
* Delivery of listings, summary reports, and figures to the trial programmer, statistician, and/or appropriate members of the clinical trial team
* Maintenance of up-to-date documentation for programs, metadata, data sets, tables, listings, and figures under responsibility, and filing of relevant trial documents in the eTMF
* Discussion of data presentation methods with the trial programmer, statistician, and/or appropriate members of the clinical trial team
* Information and suggestion of solutions to critical programming issues within the department
* Programming for standard and special analyses, and provision of trial or project-specific listings, summary tabulations, and graphics to the clinical trial team
* Provision of technical advice and support to other colleagues
* Assessment, recommendation, and development of new standards, policies, and procedures
* Support of the implementation of computerized systems and tools that facilitate trials/projects data analysis and data flow, including handling of organizational aspects
* Compliance with ICH-GCP regulations and company SOPs
* Contribution to and leadership of initiatives and non-clinical projects
Required Skills and Qualifications
* Relevant working/residency permit or Swiss/EU citizenship required
* University degree (or equivalent) preferably in mathematics, informatics, or another scientific discipline
* Advanced knowledge of programming in SAS and statistical analyses in clinical trials
* Good knowledge and understanding of CDISC, especially SDTM and ADaM
* Basic knowledge of R, knowledge of other programming languages, and data management principles and tools is an asset
* Ability to analyze problems and formulate ideas in a structured and logical manner
* Able to work according to operating procedures, specifications, and timelines
* At least four years of experience in statistical programming, of which at least three within a pharmaceutical company or a clinical research organization (CRO)
* Ability to communicate effectively in English
* Knowledge of international clinical research regulations and requirements (ICH-GCP)
* Excellent interpersonal and communication skills
* Able to work independently with a commitment to achieve common goals
Benefits
This role offers a unique opportunity to work on challenging projects, develop your skills, and contribute to the success of our team.
The ideal candidate will be a highly motivated individual with excellent communication and analytical skills, who is able to work independently and as part of a team.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.