Key Responsibilities:
- Provide statistical expertise in the design execution and analysis of clinical trials.
- Collaborate closely with cross-functional teams including clinical and regulatory stakeholders.
- Deliver high-quality statistical inputs for clinical development plans and health authority (HA) submissions.
- Report to a Franchise Team Leader within the Biostatistics & Statistical Modeling department.
- Ensure compliance with company policies and regulatory standards.
Qualifications:
- Masters degree in Statistics or a related field (Ph.D. preferred).
- Minimum 5 years of biostatistics experience in drug development (doctoral research may count toward experience).
- Strong understanding of biostatistical methods and clinical trial design.
- Proficiency in statistical programming tools particularly SAS and/or R.
- Ability to independently manage statistical deliverables across multiple trials.
- Excellent communication skills with the ability to simplify complex statistical concepts.
- Strong team orientation and ability to work in a dynamic fast-paced biotech environment.
Preferred Skills & Experience:
- Knowledge of eCRT and Define standards.
- Prior experience with regulatory submissions.
- Therapeutic area experience in Immunology is a plus.
- Familiarity with modern statistical models and trial design approaches.
- Demonstrated project leadership and ability to work with cross-functional teams.
- Proactive communicator with a solution-oriented mindset.
Note for Suppliers:
Candidate must be located on the U.S. East Coast.