Senior Statistical Programmer

The Role & What You Will Be Doing

The Senior Statistical Programmer is responsible for the development, validation, and delivery of high-quality statistical programming outputs to support clinical trials and regulatory submissions. The role ensures datasets, tables, listings, and figures are compliant with regulatory standards and company procedures. The Senior Statistical Programmer provides technical expertise, oversight, and mentorship within cross-functional study teams. This position contributes to efficient study execution and regulatory approval by ensuring accurate, reproducible, and submission-ready programming deliverables. The role may also lead programming activities across one or more clinical studies.

Every day, we rise to the challenge to make a difference and here’s how the Senior Statistical Programmer role will make an impact:

• 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 his/her 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

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• A master’s degree or equivalent is required, preferably in mathematics, informatics, or another scientific discipline.
• 3 years of experience in statistical programming within pharmaceutical company or CRO is required.
• Advanced English language knowledge is required.
• 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.
• 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