Our client is a biotechnology company focused on developing innovative cancer treatments through precision medicine. Their approach utilizes synthetic lethality to create therapies targeting significant cancer markers, including tumor suppressor gene loss, enhancing immune response against cancer cells.
Summary
In this role, reporting to the Vice President of Biometrics, you will collaborate with clinical teams, overseeing statistical deliverables and working closely with clinical CROs. This is a unique opportunity to contribute to transformative therapies, requiring effective communication, self-motivation, and proactive thinking.
Your Role
Serve as a biostatistics expert for the client's clinical programs
Provide strategic input to optimize trial designs in both early and late-phase studies
Collaborate with internal and external CRO teams on statistical deliverables
Conduct statistical modeling to design robust, efficient studies and address statistical challenges
Contribute to protocol development, clinical trial analysis plans, and oversight of deliverables
Review eCRF designs and ensure statistical input for clinical documentation
Perform QC/QA on statistical deliverables and participate in regulatory submission support
Address statistical queries from regulatory agencies and support publication efforts
Lead process improvements in biostatistics and represent the client in external statistical meetings
Qualifications
PhD or MS in statistics/related field with relevant industry experience
Expertise in clinical trial design, analysis, and regulatory submissions (INDs, NDAs, etc.)
Familiarity with FDA, EMA, ICH guidelines, and data standards
Proficiency in SAS, R, and statistical programming, with experience managing CRO collaborations
Strong communication skills for translating complex statistical concepts effectively
The client is an equal opportunity employer that values diversity and prohibits discrimination across various demographics.