About the role
- Provide comprehensive statistical support throughout clinical studies.
- Conduct statistical analyses of clinical data and interpret the results.
- Engage with regulatory bodies such as the FDA and EMEA.
- Provide support for Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB).
- Solid understanding and implementation of Clinical Data Interchange Standards Consortium (CDISC) requirements.
- Extensive hands-on experience in statistical analysis using SAS.
- Actively engage with clients to understand their statistical and analytical needs.
Requirements
- MSc or PhD in Biostatistics or Statistics
- Oncology Experience Required
- 10+ years of experience as Biostatistician and working in a CRO/Pharma/Biotech company
- 3+ years of experience in leading team of biostatisticians and statistical programmers and working in a CRO/Pharma/Biotech company
- Strong written and verbal communications skills, including proficiency in the English language
- Proficient in statistical programming languages such as SAS, R, or Python
- Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures, TLFs proficiency
- Strong knowledge of regulatory guidelines and statistical methodology related to clinical development.
- Cross functional collaboration & Stakeholder management
- Strong knowledge of ICH guidelines.
- competitive salary
- paid time off
- healthcare and retirement benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysisSASRPythonBASESTATMACROGRAPHclinical data analysisstatistical programming
Soft skills
strong written communicationstrong verbal communicationcross functional collaborationstakeholder management
Certifications
MSc in BiostatisticsPhD in Statistics