Director, Biostatistics

Zenas BioPharma•Waltham, MA

5d•$198,400 - $248,000•Hybrid

About The Position

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation ! Position Summary: The Director, Biostatistics is responsible for leading the development and execution of statistical aspects for global clinical programs. He/she will provide project leadership and hands-on technical statistical support.

Requirements

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.

Nice To Haves

Submission experience is strongly preferred.

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.