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Principal statistical programming consultant (eu)

Aachen
TechBiz Global GmbH
Consultant
Inserat online seit: Veröffentlicht vor 21 Std.
Beschreibung

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:

o Clinical Study Reports (CSRs)

o Safety reports

o 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:

o Data issues

o Outliers

o Specification clarifications

o Timelines and deliverables

* Follow Standard Operating Procedures (SOPs) and Quality Management Systems

* Support hiring activities by:

o Identifying skill requirements

o Conducting technical interviews




Education

* Bachelor’s or Master’s degree in:

o Computer Science

o Statistics

o Biostatistics

o 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:

o CDISC standards (SDTM, ADaM)

o Data migration and transformation

o TLF generation (Tables, Listings, Figures)

* Understanding of:

o Drug development lifecycle

o 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

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