TechBiz Global is hiring a Principal Statistical Programming Consultant to deliver high-quality statistical programming outputs for global clinical trials. In this role, you will be responsible for activities spanning early-phase studies, publications, and regulatory submissions, working under the direction of a Team Lead or Project Manager.
What You'll Do
- Perform statistical programming activities for clinical trials, including early-phase projects, indications, and publications.
- Lead at least one study team, providing technical and domain expertise.
- Manage and mentor a small team of 2–4 programmers (if required).
- Develop and validate SAS analysis datasets, tables, listings, and figures (TLFs) based on specifications.
- Create programs for graphs and tables used in Clinical Study Reports (CSRs), Safety reports, and Efficacy reports.
- Work on data migration from legacy datasets to standards such as CDISC or client-specific formats.
- Read, interpret, and implement program specification documents.
- Perform data validation and transformation according to client requirements.
- Validate TLFs to ensure accuracy, quality, and compliance.
- Collaborate with clients and global teams to resolve data issues, outliers, specification clarifications, timelines, and deliverables.
- Follow Standard Operating Procedures (SOPs) and Quality Management Systems.
- Support hiring activities by identifying skill requirements and conducting technical interviews.
What We're Looking For
- Bachelor’s or Master’s degree in Computer Science, Statistics, Biostatistics, Life Sciences or related field.
- Minimum 5+ years of SAS programming experience in clinical trials.
- Mandatory experience in Oncology Therapeutic Area (TA).
- Experience working with clinical trial data and regulatory submissions.
- Strong proficiency in SAS programming.
- Hands-on experience with CDISC standards (SDTM, ADaM).
- Hands-on experience with data migration and transformation.
- Hands-on experience with TLF generation (Tables, Listings, Figures).
- Understanding of drug development lifecycle.
- Understanding of regulatory requirements (e.g., FDA, EMA).
- Ability to work independently and manage multiple priorities.
- Strong analytical and problem-solving skills.
- Excellent communication skills (written and verbal).
- Leadership and mentoring capabilities.
Nice to Have
- Experience leading small teams or study teams.
- Exposure to global client environments.
- Experience contributing to recruitment/interview processes.
Technical Stack
- SAS
- CDISC (SDTM, ADaM)
Team & Environment
You will work under the direction of a Team Lead or Project Manager. The role includes managing and mentoring a small team of 2–4 programmers if required.
Benefits & Compensation
- Opportunity to work on global clinical trials.
- Collaborative and supportive team environment.
- Career growth and leadership opportunities.
Work Mode
This is a global role. The position is located in Petten, Noord-Holland, Netherlands, and is open to remote work.
TechBiz Global is an equal opportunity employer.
