Head of Biostatistics

JobsCloseBy Editorial Insights

Zenas BioPharma seeks a Head of Biostatistics to provide strategic leadership for clinical programs, drive trial design and analysis, oversee biostatistics teams, and manage CROs and regulatory oversight, in collaboration with Clinical Development, Regulatory Affairs, Data Management and Pharmacovigilance. Ideal candidates hold a PhD in statistics or biostatistics with 10+ years in clinical trials (MS with 15 years accepted), with phase 3 and POC trial experience and a track record in small biotech, SAS expertise, ICH GCP knowledge, and strong regulator and executive communication. Onsite in Waltham, MA with hybrid options. To apply, tailor your resume to show impact, program leadership, mentoring, vendor oversight, and concrete examples of translating statistics into decisions.

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 Head of Biostatistics role is accountable for overall leadership of Biostatistics function, providing statistical leadership and strategic input for all clinical programs and studies as well as managing and leading the biostatistics and statistical programming team.  He/she will work closely with clinical development, clinical operations, clinical pharmacology, pharmacovigilance, regulatory affairs, and project management in the development and implementation of clinical development strategy and plan to ensure that statistical elements are aligned with 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.

Key Responsibilities:

• Provide strategic leadership in biostatistics across all phases of clinical development.
• Oversee statistical design, analysis, and interpretation of clinical trials.
• Bring innovative statistical thinking and methods to help drive applications of statistical methods that enhance the probability of success for clinical development programs
• Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Data Management.
• Ensure compliance with regulatory requirements and industry best practices.
• Develop and mentor a high-performing biostatistics team.
• Manage external vendors and CROs for statistical support.
• Interact with regulatory agencies, and effectively address statistical questions and requests
• Represent biostatistics function at executive meetings, advisory board meetings, and meetings with KOLs

Qualifications:

• PhD in statistics, biostatistics, or related field with at least 10 years of experience in clinical trials is preferred; or MS in statistics, biostatistics, or related field with 15 years of experience in clinical trials
• Excellent understanding of and experience implementing statistical principles and clinical trial methodology
• Experience working on all phases of clinical trials, particularly phase 3 and POC clinical trials
• Previous experience working in small biotech is preferred
• Demonstrated experience working with and overseeing CROs, vendors and other external partners is preferred
• Understanding of ICH GCP as well as knowledge of industry practices and standards.
• Fluency in English, both oral and written
• Ability to manage people and projects
• Excellent written and oral communication and presentation skills
• Expertise in SAS and familiarity with other statistical software
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, and Project)

#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 $248,800 to $311,000. 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.