Director, Biostatistics

Director, Biostatistics

Zenas Bio Pharma

The Director, Biostatistics is responsible for leading the development and execution of statistical aspects for global clinical programs. The Director will provide project leadership and hands‑on technical statistical support.

• Independently lead the development and execution of all statistical aspects for one or more clinical development programs, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
• Manage biostatistics and programming vendors.
• Take accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.
• Work as part of a collaborative, cross‑functional team with members from other disciplines.
• Represent Biostatistics, ensuring statistical input is provided throughout the clinical development process.
• Interact with regulatory agencies, and effectively address statistical questions and requests.
• Lead or contribute to departmental initiatives for process improvement, standardization, and the development or implementation of tools and processes to enhance efficiency and quality.
• Mentor and/or manage junior staff.
• Review or author statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications.
• Generate or review study randomization, sample size/power estimations and key specifications for statistical programming implementation of analyses including programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications.
• Develop statistical programs to ensure quality and accuracy or to perform other pre‑specified or ad‑hoc analyses as required.

• PhD or MSc in Biostatistics or related discipline, 8+ years of experience working across all phases of clinical trials in CRO/Biotech/Pharmaceutical company.
• Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials.
• Experience working with CROs and vendors.
• Good knowledge of ICH, FDA, EMA, and NMPA guidelines.
• Prior experience supporting global clinical trials.
• Project leadership experience.
• Submission experience is strongly preferred.
• Exceptional interpersonal skills and problem‑solving capabilities.
• Excellent oral and written communication skills and ability to effectively communicate statistical concepts to both technical and non‑technical stakeholders.
• Experience working with cross‑functional teams, including clinical development, regulatory affairs, medical affairs and commercial.
• Experience working with CDISC data standards.
• Proficiency in SAS programming and other statistical software tools.

Zenas is committed to fair and equitable compensation practices. The base salary for this role is $198,400 to $248,000. Actual compensation packages will depend on experience, education, skill set, overall performance and location. The total rewards include annual performance bonus, equity, full range of benefits, and other incentive compensation plans.

Zenas Bio Pharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.