Zenas BioPharma
Senior Director, Biostatistics
Waltham, MA · Director
Sponsorship not specified$227k-$284kDetected 21 days ago
GCPStatisticsSAPProcess ImprovementCompensationClinical TrialsClinical ResearchFDA RegulatorySASResearchAnimal StudiesLeadershipCommunicationProblem SolvingBiostatisticsRegulatory Affairs
About the role
- 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.
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.
- 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.
- Review or author statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications.
- 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.
Requirements
- PhD in statistics, biostatistics, or related field with at least 10 years of experience in clinical research and drug development
- Understanding of ICH GCP as well as knowledge of industry practices and standards
- Excellent oral and written communication skills and ability to effectively communicate statistical concepts to both technical and non-technical stakeholders.
- Proficiency in SAS programming and other statistical software tools.
- 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
- Prior experience supporting global clinical trials.
- Exceptional interpersonal skills and problem-solving capabilities.
- Experience working with cross-functional teams, including clinical development, regulatory affairs, medical affairs and commercial.
- 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.
- #LI-Hybrid
Nice to have
- NDA/BLA submission experience is preferred.
Compensation
- The position is eligible for a competitive compensation and benefits package.
Company info
- 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.
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