Associate Director of Biostatistics

Join a Cutting-Edge Biopharmaceutical Company Revolutionizing RNA Therapies

This opportunity is with a rapidly growing biopharma company dedicated to improving lives through innovative RNA-based therapeutics. Our proprietary platform combines targeted delivery with precision molecular therapies, unlocking new possibilities for treating diseases previously deemed untreatable. Our commitment to patient-focused innovation drives our collaborative, agile, and integrated culture.

The Opportunity

We are seeking an Associate Director of Biostatistics to provide strategic and technical leadership for clinical trials. This individual will oversee study design, statistical analyses, and regulatory submissions, contributing to groundbreaking programs. Additionally, this role will support cross-functional teams and department-wide initiatives to ensure the highest scientific and regulatory standards.

Responsibilities

• Develop statistical analysis plans (including ISS/ISE), and review CRFs, TFL shells, and specifications.
• Manage and oversee CRO activities, ensuring high-quality statistical analyses and outputs.
• Contribute to study design, randomization processes, and documentation such as protocols and IDMC charters.
• Present study results, and author regulatory documents, CSRs, and publications.
• Support regulatory submissions and responses, ensuring readiness for product registration or reimbursement.
• Collaborate with cross-functional teams on product development strategies, including innovative trial designs.
• Advance department standards and processes, and mentor team members on statistical methodologies.

Qualifications

• Education: Ph.D. in Biostatistics/Statistics with 8+ years or M.S. with 10+ years of experience in biostatistics within the pharmaceutical industry.
• Proficiency in statistical methods for all phases of clinical trials and familiarity with regulatory guidance (e.g., ICH, FDA, EMA).
• Hands-on experience with CDISC standards (SDTM, ADaM) and statistical software (SAS, R, Python).
• Strong track record in leading statistical contributions for NDAs/BLAs/MAAs, including regulatory interactions.
• Excellent organizational, communication, and problem-solving skills, with the ability to thrive in a fast-paced environment.

Preferred Experience

• Expertise in rare diseases or advanced statistical techniques, such as adaptive designs or machine learning.
• Familiarity with real-world data analysis or longitudinal data modeling.