Senior Director, Biostatistics
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is looking for an exceptional individual to join our growing team as the Senior Director, Biostatistics reporting to the Chief Medical Officer.
- Develop statistical strategy for clinical development programs across multiple therapeutic areas
- Provide expert statistical input to Phase I - IV global clinical trials, lifecycle management, and translational medicine research efforts
- Ensure appropriate statistical methodologies are applied to study designs and data analyses
- Support the project team and clinical study team including the derivation of go/no-go criteria, generation of data visualizations and summary reports, and interpretation of results
- Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results
- Author and review critical documents such as briefing documents, synopses, protocols, statistical analysis plans (SAPs), top-line reports, clinical study reports (CSRs), and integrated summaries
- Represent the statistical function at meetings with regulatory authorities, key opinion leaders and other specialist bodies and defending statistical approaches
- Lead statistical efforts for regulatory submissions and correspondences with health authorities
- Stay current with advances in the field and ensure appropriateness of internal practices
- Review and provide feedback to statisticians at Contract Research Organizations (CROs) and vendors
- Develop and maintain long-term relationships with key statistical opinion leaders within academia, regulatory agencies, and industry
- Drive innovation by implementing new methodologies and statistical designs
- Define the vision for the Biostatistics function, including hiring, mentoring, and retention of the Biostatistics group
- Master's or Doctorate degree in Mathematics, Biostatistics or Statistics
- Ten years post-graduate statistical experience in the biotechnology or pharmaceutical industries
- Knowledgeable of statistical methodology and applications within drug development, especially in oncology
- Experience in statistical methodologies related to adaptive designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian adaptive design) and/or combined phase 1/2 or phase 2/3 designs
- Advanced programming skills in SAS, R, and other relevant statistical software solutions.
- Experience as statistical lead in regulatory submissions
- Effective communication and presentation skills
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.