POSITION/TITLE: Statistical Analyst - Oncology
Department: Medical Affairs Statistics
Location: Whippany, NJ
Initial duration 6-12 months with expected extension.
The primary responsibility of the 'Statistical Analyst' is to work closely with statisticians and perform data analyses for Medical Affairs studies/projects in the area of oncology: post-marketing observational and real world evidence (RWE) studies, collaborative clinical studies and regulatory submissions.
POSITION DUTIES & RESPONSIBILITIES
- Provide statistical programming support for assigned studies /projects, focusing on RWE data analyses from large databases (e.g., Electronic Health Records, medical claims, registries etc.)
- Provide technical expertise to implement statistical methodology for complex studies
- Develop and implement standard programs and/or programming templates, as needed
- Create TLF and dataset specifications, in collaboration with statisticians
- Guide/Oversee CRO programmers for outsourced studies
- Ensure quality and timely deliverables for all assigned studies/projects
- Perform ad-hoc/exploratory data analyses, as needed
- Participate in the sNDA activities, as needed
- Collaborate with global cross-functional teams
- BS/MS in Statistics/Biostatistics/Epidemiology/Computer Science or a related field
Skill & Competency Requirements
- 5 + years statistical programming with SAS or R in pharmaceutical or biotech
- Excellent interpersonal, presentation and communication skills; Self starter
- Programming experience in SDTM or ADAM data structures is preferred
- Programming experience in observational studies is a plus
- Programming experience with large RWE databases such as FlatIron/Optum/Truven is preferable
- Oncology experience is preferred
Sthree US is acting as an Employment Business in relation to this vacancy.