Responsibilities
As a Statistical Programmer, you will be in charge of the statistical analysis of clinical studies.
You will:
- Create data transfer specifications as per a blinding plan
- Read data from external sources in SAS
- Integrate and reconcile all eCRF and external data into a clinical database
- Convert databases into the standard clinical formats like CDISC-SDTM and CDISC-ADaM
- Program data lists to support data management activities: edit checks, patients lists, clinical coding, lab conversion and patients profiles
- Program lists for data safety monitoring boards and other independent committees
- Write programs for the efficacy and safety analysis of clinical trials, based on the statistical analysis plan.
- Program lists for regulatory submissions, for example BIMO lists
- Consolidate the output of the statistical analysis in tables, figures and listings (TFL)
- Create macros to automate tasks across projects
Requirements
Education:
- A graduate degree in Informatics or a master’s degree in a numerate field like Mathematics, Physics, (Bio-/Commercial-) Engineer or similar through experience.
- A degree in Statistics is a plus.
Experience:
- Minimum of 3 years of experience in clinical research
Skills:
- Experience with SAS or R programming
- The following skills are considered a plus:
- Knowledge of CDISC CDASH, SDTM and ADaM
- Knowledge of ICH-GCP and other guidelines in clinical research
- Good IT literacy including MS Office, Adobe, etc.
- Knowledge of Github or similar tools is considered a plus
- Excellent verbal and written skills in English - knowledge of Dutch or French is a plus
Key competencies
- Integrity
- Focus with an eye for detail
- Achievement orientation and high energy
- Excellent communication & collaboration skills
- Can do attitude and the flexibility to engage in a variety of tasks
- Entrepreneurial mindset with a customer obsession
- Growth mindset to continuously learn and stay on top of latest developments
- The ability to work autonomously, as well as collaboratively in a team, in an atmosphere where giving constructive feedback is a must
We offer
- A competitive package with extra-legal benefits
- A young and dynamic work environment
- A strong commitment to your professional growth and continuous development
- A career path that is based on meritocracy with real growth possibilities
- An easy to reach office & possibilities to work from home. We promote hybrid working arrangements