Sobre este puesto de Associate Director, Statistical Programming en Zenas BioPharma
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 discipline, 7+ years’ experience working across all phases of clinical trials in CRO/Biotech/ Pharmaceutical company; or Bachelor’s degree with 9+ years of relevant experience.
- Experience managing CROs and vendors.
- NDA/BLA and other regulatory filing experience.
- Experience with ISS/ISE.
- Strong knowledge of CDISC standards for SDTM and ADaM.
- Strong knowledge of ICH, FDA, EMA, and NMPA regulations and guidelines.
- Exceptional interpersonal skills and problem-solving capabilities.
- Excellent oral and written communication skills.
- Experience working with cross-functional teams.
- Excellent SAS programming skills.
- Experience with other statistical software tools (e.g., R) preferred.
- 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.
#LI-Hybrid
The position is eligible for a competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $171,500 to $214,423. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma 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.
