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Zenas BioPharma — Waltham, Massachusetts
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 Associate Director, Statistical Programming will independently lead and execute programming activities aligned with project strategies to support clinical studies, study reports, and regulatory submissions.
This role extends beyond study support to include strategic contributions to departmental infrastructure, such as process optimization and tool development. The position also involves direct management and oversight of internal, contract, and FSP programming resources.
Key Responsibilities
: Act as the primary statistical programming contact and knowledge expert for assigned protocols, studies, and integrated analyses. Provide oversight of statistical programming activities, including those of internal staff, CROs, and FSP teams. Ensure deliverables meet quality standards, study timelines, and agreed scope.
Collaborate across functions (e.g., Biostatistics, Data Management, Clinical Operations) to provide expert programming support and strategic input.
Lead or contribute to departmental initiatives for process improvement, standardization, and the development or implementation of programming tools and macros to enhance efficiency and quality. Review and provide expert input on SDTM and ADaM specifications, datasets, define.xml, reviewers guides, and validation reports.
Perform QC of SDTM datasets, ADaM datasets, and Tables, Figures, and Listings (TFLs). Program TFLs for ad hoc analyses, posters, publications, and regulatory interactions. Participate in the review of clinical study protocols, statistical analysis plans, and mock TFL shells.
Mentor, guide, and provide line management to junior programmers and assigned contract/FSP resources. Manage relationships and performance with contract programming resources and Functional Service Providers (FSP).
Qualifications
: Master’s degree in Biostatistics, Computer Science or related disc