Senior Statistical Programmer

Job Title: Senior Statistical Programmer

Work Location: Allschwil

Country: Switzerland

Schedule: Fulltime (100%)

Desired start date: ASAP (Preferably not after mid-March)

Duration: 12 months

RESPONSIBILITIES AND TASKS:

• Responsible for the implementation and use of programs to effectively analyze and report clinical trial data as the trial 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 trial programmer and/or statistician, designs and implements trial and project analysis data sets and metadata including complex data derivations, data mapping and data pooling.
• Informs and suggests solutions to the trial programmer and/or statistician on critical issues within the project.
• 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 trial programmer and/or the statistician.
• Performs and documents quality control (QC) activities as per company standard operating procedures.
• (SOPs), working practices and guidance from the trial programmer.
• Delivers listings, summary reports and figures to the trial programmer, the statistician and/ or appropriate members of the clinical trial team as per the project timelines.
• Maintains up-to-date documentation for the programs, metadata, data sets, tables, listings and figures that are under your responsibility and files all relevant trial documents in the eTMF.
• Discusses data presentation methods with the trial programmer, statistician and/ or appropriate members of the clinical trial team.
• Informs and suggests solutions to the trial programmer, principal programmer and/or department head on critical programming issues within the department.
• Performs the programming for standard and special analyses and provides the appropriate members of the clinical trial team with trial or project-specific listings, summary tabulations and graphics.
• Provides technical advice and support to other colleagues.
• Assesses, recommends and develops new standards, policies and procedures.
• Supports the implementation of computerized systems and tools that facilitate the trials/projects data analysis, and data flow, including the handling of organizational aspects.
• Complies with ICH-GCP regulations and company SOPs.
• Contributes to and leads initiatives and non-clinical projects.

REQUIRED QUALIFICATIONS AND EXPERIENCE:

• University degree (or equivalent) preferably in mathematics, informatics, or another scientific discipline.
• Advanced knowledge of programming in SAS and of 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 of data management principles and tools is an asset.
• Ability to analyze problems and formulate ideas in a structured and logical manner.
• Must be able to work according to operating procedures, specifications and timelines.
• At least five years of experience in statistical programming, 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.
• Ability to work independently with a commitment to achieve common goals.

Apply:
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.