Senior Director, Biostatistics

Zenas BioPharma•Waltham, MA

1d•$227,400 - $284,256•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 ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody. 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 Senior Director of Biostatistics is accountable for providing statistical leadership and strategic input for one or more clinical development programs. He/she will work closely with cross-functional teams to ensure that statistical elements are aligned with the overall program strategy. He/she will participate in interactions with regulatory agencies, and prepare statistic section of protocols, clinical study reports, and regulatory submission materials. He/she will provide oversight to CRO partners and vendors to ensure project timelines and goals are met. This is a strategic role, with hands-on involvement, as well.

Requirements

PhD in statistics, biostatistics, or related field with at least 10 years of experience in clinical research and drug development
Excellent understanding of and experience implementing statistical principles and innovative clinical trial methodology
Demonstrated experience working with and overseeing CROs, vendors and other external partners
Understanding of ICH GCP as well as knowledge of industry practices and standards
Prior experience supporting global clinical trials.
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.
Proficiency in SAS programming and other statistical software tools.
Ability to manage people and projects
Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.

Nice To Haves

NDA/BLA submission experience is preferred.

Responsibilities

Set biostatistical strategy for one or more clinical development programs, including clinical development plans, contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
Manage biostatistics vendors.
Take accountability for ensuring quality across all statistical aspects of clinical development program.
Foster a culture of scientific rigor and cross-functional collaboration.
Represent Biostatistics, ensuring statistical input is provided throughout the clinical development process.
Serve as primary biostatistics lead for major regulatory interactions. Shape briefing book content, respond to RFIs and ensure inspection readiness.
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/manages junior level statisticians, as required.
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.