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Principal Statistical Programming Consultant (EU)

TechBiz Global GmbH
Brussel

Snel solliciteren

Vacaturegegevens

Voltijds

Kwalificaties

Computerwetenschappen
Informatica
Data migration
SAS
Master
Bachelor
Personeelswerving
Managementervaring
Communicatieve vaardigheden
FDA-regulaties

Volledige vacaturetekst

At TechBiz Global, we are providing recruitment service to our TOP clients from our portfolio. We are currently seeking a Principal Statistical Programming Consultant (EU) to join one of our clients' teams. If you're looking for an exciting opportunity to grow in a innovative environment, this could be the perfect fit for you. In this role, you will work under the direction of the Team Lead or Project Manager and be responsible for delivering high-quality statistical programming outputs for clinical trials, including early-phase studies, publications, and regulatory submissions.

Key Responsibilities

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
- 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 (e.g., US team) 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
- Conducting technical interviews

Education

Bachelor’s or Master’s degree in:
- Computer Science
- Statistics
- Biostatistics
- Life Sciences or related field

Experience

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

Technical Skills

Strong proficiency in SAS programming
Hands-on experience with:
- CDISC standards (SDTM, ADaM)
- Data migration and transformation
- TLF generation (Tables, Listings, Figures)
Understanding of:
- Drug development lifecycle
- Regulatory requirements (e.g., FDA, EMA)

Soft Skills

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

What We Offer

Opportunity to work on global clinical trials
Collaborative and supportive team environment
Career growth and leadership opportunities

Snel solliciteren

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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van programmeur in londerzeel

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