Website AcademicMedCtr Academic Medical Center
Leading medical innovation, advancing patient care
Job Description
About the Role
Lead statistical strategy for Phase 3/4 oncology trials and drive regulatory submissions. Design adaptive trial methodologies while managing teams of statisticians and statistical programmers. Your analyses will inform critical drug development decisions for novel immuno-therapies targeting $1B+ markets.
Responsibilities
- Develop statistical analysis plans for FDA submissions
- Oversee analytical work for IND/NDA/BLA filings
- Innovate trial designs using Bayesian methodologies
- Manage CRO partnerships for statistical deliverables
- Present results to executive leadership and DSMBs
- Implement ML techniques for clinical data analysis
- Mentor 15+ statisticians and programmers
Requirements
- PhD in Biostatistics or Statistics
- 10+ years Pharma/Biotech experience
- Expertise in oncology clinical trial design
- Proven FDA submission record (eLNBs, ISS/ISE)
- Advanced SAS/R/Python programming skills
- Experience with CDISC standards (SDTM/ADaM)
- Publications in major medical journals
- Knowledge of ICH E9/E10/E17 guidelines
Benefits
- $20k annual bonus potential
- 401(k) with 8% company match
- Executive health screenings
- Onsite childcare facility
- Publication reward program ($10k)
- Conference presentation opportunities
- Four weeks starting PTO
- Patent royalty participation
About the Company
OncoPharm Innovations pioneers targeted cancer therapies using pioneering biomarker technology. Our Boston hub features state-of-the-art labs and collaborative research centers. Named among Science Magazine’s Top 10 Biotech Employers for innovation culture and development pipeline.
Job ID: head-of-biostatistics-LkdlS
