Pivotal is excited to expand our team and we are looking for an experienced, highly motivated SDTM Programmer who shares our vision of providing clinical research excellence.
Joining Pivotal as a STDM Programmer who, means that you will enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation.
This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company.
You'll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
Why Pivotal: We are passionate and fully committed with medical science while using technology, to make a positive impact We provide an exceptional experience.
We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong Your responsibilities will include: The ideal candidate will specialize in the creation and validation of Study Data Tabulation Model (SDTM) datasets to ensure regulatory compliance for clinical trials.
A strong command of R programming, coupled with familiarity with CDISC standards, is required for this role.
Develop and validate SDTM datasets to meet CDISC standards and regulatory requirements (FDA, EMA).
Collaborate with clinical data managers, statisticians, and study team members to ensure accurate data transformation and standardization.
Write and validate R scripts for data analysis, cleaning, and mapping to SDTM datasets.
Review case report forms (CRFs) and annotated CRFs to ensure compatibility with SDTM requirements.
Generate SDTM domains, including custom domains when needed, and ensure dataset readiness for submission.
Conduct quality control (QC) of SDTM datasets and associated documentation.
Produce Define.xml and metadata files to support SDTM datasets.
Automate processes for dataset generation and validation using R. Stay updated on CDISC guidelines, regulatory changes, and R programming advancements.
Required profile: Bachelor's or Master's degree in Computer Science, Biostatistics, Life Sciences, or a related field.
Experience in R programming with a focus on data wrangling, validation, and statistical analysis.
Experience with clinical data programming tools (e.g., SAS, Python, RStudio or VSCode).
Ability to understand xml and json files.
Familiarity with database structures.
Experience with Git for version control.
Familiarity with reporting and data visualization using R libraries (e.g., ggplot2, shiny).
Skills: Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures Strong written and verbal communication skills, attention to detail and ability to work in a fast-paced environment Ability to work autonomously Fluent in English Good knowledge of Office (Word, Excel and PowerPoint) What you can expect: Resources that promote your career growth Leaders that support flexible work schedules Trainings to help you build your therapeutic knowledge Dynamic work environments that expose you to new experiences Commitment to Equal Opportunity: At Pivotal, we believe that diversity and inclusion are essential to the success of our team.
We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.