The Bioforum Biometrics department is growing, and we have an opportunity for an experienced statistical programmer to join our group. This position is in the United States of America (North America).
Required skills:
- Minimum 6 years’ experience as a statistical programming working on clinical trials.
- Good knowledge of TFL programming.
- Experience in programming according to CDISC standards (SDTM, ADaM), and preparing documents for submission (Reviewer’s Guide, Define.xml)
- Attention to details.
- Excellent communication skills.
- A bachelor’s degree in either statistics , computer or life science discipline
Duties will include:
- Participating in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.
- Might need to be responsible for project management (timelines, scope, budget, resourcing) on a project or program level.
- Train, mentor and share knowledge with the rest of the statistical programming team.
- Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc.).
- Might include Interaction with customers on a project or program level.
- Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.
- Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.
- Development of SAS programs for study TFLs, based on study SAP and shells.
- Review and verify all types of conversions and programming done based on customer requirements.
- Development of core programs for validation, conversion, and maintenance of clinical data dataset structure.
- Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.
Skills Required
- Minimum 6 years' experience as a statistical programmer working on clinical trials
- Good knowledge of TFL programming (tables, figures, listings)
- Experience programming according to CDISC standards (SDTM, ADaM) and preparing submission documents (Reviewer's Guide, Define.xml)
- Experience developing SAS programs for data conversion, analysis datasets, and TFLs
- Ability to create programming specification documents (SDTM, ADaM, derived data)
- Attention to detail
- Excellent communication skills
- Bachelor's degree in statistics, computer science, or a life science discipline
What We Do
Bioforum is a biometric contract research organization that provides clinical data solutions for pharmaceutical, biotechnology, and medical-device sponsors. Its services include clinical data management, biostatistics, statistical programming, medical writing, data integration, and regulatory-ready reporting. Bioforum helps optimize clinical-trial design, data collection, analysis, and oversight, supporting sponsors throughout the development process and accelerating delivery of new therapies to patients.
