Zenas BioPharma · 1 day ago
Director, Biostatistics
Waltham, MA
Full-time
Onsite
Director/Executive
$198K/yr - $248K/yr
8+ years expZenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases. The Director, Biostatistics will lead the development and execution of statistical aspects for global clinical programs, providing project leadership and technical statistical support while ensuring quality in all planning and execution of assignments.
BiopharmaHealth CarePharmaceutical
Responsibilities
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
Generates or reviews 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
Qualification
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
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
Preferred
Submission experience is strongly preferred
Benefits
Annual performance bonus
Equity
Full range of benefits
Other incentive compensation plans
Company
Zenas BioPharma
Zenas BioPharma is a biopharmaceutical company that focuses on developing immune-based therapies for patients.
51-200 employees
H1B Sponsorship
Zenas BioPharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$513MKey Investors
Royalty PharmaEnavate Sciences
2025-10-08Post Ipo Equity· $120M
2025-09-02Post Ipo Debt· $75M
2024-09-13IPO
Leadership Team
Lonnie Moulder Jr
Founder and Chief Executive Officer
Orlando Oliveira
Chief Commercial Officer
Recent News
2026-01-07
2026-01-06
2026-01-06
Company data provided by crunchbase