Lead and manage biostatistical activities across a complex portfolio of gene therapy studies, collaborating with cross-functional partners to meet clinical development project deliverables and timelines.
Requirements
- PhD in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment.
- MS in biostatistics or related discipline with 10+ years’ relevant experience in statistical analysis of biomedical data using SAS or equivalent software.
- Extensive biomedical statistical analysis experience and experience working with relevant software.
- Experience developing software and other tools to support statistical analysis of biomedical or related data.
- Strong proficiencies in software and other tools used typically used by Biostatistics.
- Demonstrated excellence in complex project management and effectively managing multiple projects and priorities.
- Experience working with CROs for data and programming deliverables.
- Experience leveraging AI and machine learning to enhance clinical trial design, analyses and decision-making is preferred.
- Has an expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects.
- Has extensive knowledge of statistical designs, applicable to clinical trials in rare disease which allow for robust study results in smaller datasets.
- Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
- Has in-depth understanding of the cross-functional roles and responsibilities involved in drug development.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures
- Strong communication and organizational skills.
- Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees
- Ability to handle multiple development programs simultaneously.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
- Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction.
- Analytical and problem-solving capabilities.
- Collaborative and collegial work style.
- Attention to detail and follow-up.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
