The role involves delivering biostatistics and programming activities throughout the Vaccines R&D value chain including Pre-Clinical, Clinical, Translational, and CMC phases
Job Summary
The role involves delivering biostatistics and programming activities throughout the Vaccines R&D value chain including Pre-Clinical, Clinical, Translational, and CMC phases.
Candidates will lead the creation of compliant CDISC data packages and integrated clinical databases for reporting purposes like ISS/ISE/ISI and safety surveillance.
This position requires a passionate leader with excellent technical skills in SAS and R to guide junior staff and ensure high-quality timely deliverables.
Matching Summary
The role involves delivering biostatistics and programming activities throughout the Vaccines R&D value chain including Pre-Clinical, Clinical, Translational, and CMC phases.
Skills & Requirements
Must-have
6+ years statistical programming experience
SAS BASE STAT MACRO GRAPH SQL R proficiency
CDISC SDTM ADaM dataset programming expertise
Vaccine clinical trial domain knowledge
Data pooling across multiple studies
TLF creation and mock-up generation
Nice-to-have
Leadership and mentoring junior staff
Exploratory and post-hoc analysis programming
Eudract and CTT.gov publishing compliance
Strong project management skills
Cross-functional team collaboration
Key Requirements
Bachelor's or Master's degree in Statistics or related field
Minimum 6 years experience in clinical research statistical programming
At least 3 years of advanced SAS programming experience
Proven experience leading concurrent studies or projects