Principal Biostatistician

SUMMARY

The Principal Biostatistician will have a meaningful impact on clinical projects, interact directly with scientist and clinicians across the company and externally, be a core member of multi-disciplinary teams and with the VP of Biometrics, and help shape the evidence generation strategy across clinical development.

PRIMARY RESPONSIBILITY

1. Directs and leads the statistical input for more than one disease indication, including review with Research and Development management.
2. Oversees the statistical design, analysis and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
3. Actively contributes to global project and study teams as a core member
4. Partners with Data Management, SAS Programmers and Clinical Monitoring to ensure high quality data deliverables
5. Experience overseeing and reviewing work and deliverables from CROs for the full reporting of clinical trials
6. Represents department in meetings with regulatory agencies and investigators
7. Seeks advice from internal and external statistical experts in areas outside of expertise
8. Researches and programs statistical methodologies such as simulation based / Bayesian approaches, interim analyses including futility.
9. Provides hands on SAS programming for clinical studies to support the development, regulatory approval and conferences/publications for Adaptimmune T-cell therapies.
10. Deliver tables, listings and figures for conferences, publications, safety reviews and regulatory requests.
11. Proficiency in CDISC standards

QUALIFICATIONS & EXPERIENCE:

1. Master’s degree in Biostatistics or Statistics with a minimum of 3 to 5 years in a pharma/ biotech/ CRO (preferred) industry or Master's degree with a minimum of 7 years of experience in a pharma/ biotech/ CRO environment. PhD preferred
2. Extensive knowledge of SAS and other programming languages
3. Proven track record of Statistical Design, Analysis and Reporting, and Interpretation of clinical studies
4. Broad knowledge, deep expertise and superior understanding of advanced statistical concepts and techniques.
5. Experience working with clinicians, scientists, regulators and presenting at statistical and investigator meetings
6. Delivery oriented.
7. Works well under pressure and on multidisciplinary, virtual teams
8. Works independently - self-directed, high energy and strong work ethic.
9. Excellent written and verbal communication skills
10. Ability to adapt effectively to changing priorities
11. High degree of creativity, latitude and attention to detail required.
12. Demonstrates strong project management, teamwork, and interpersonal skills.