Director, Biostatistics

Belenos Biosciences Inc.; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Belenos Biosciences Inc. in the United States is seeking a Director of Biostatistics to lead statistical strategy and operations across the clinical pipeline.

You will shape study designs, SAPs, and analysis plans, while ensuring submission-ready results and rigorous data interpretation. The role requires deep expertise in advanced methods, trial design, missing data handling, and multiplicity, with oversight of CROs and regulatory interactions.

Qualifications

• PhD or Master’s degree in Biostatistics, Statistics, or related quantitative field.
• 10+ years of biostatistics experience in biotech/pharma with direct oversight of clinical trials.
• Experience with bispecific antibodies, biologics, or immunology preferred.
• Strong expertise in clinical study design, SAP development, and regulatory-grade outputs.
• Deep knowledge of CDISC, ICH E9, and regulatory expectations.
• Experience managing CROs and statistical programming teams.
• Ability to operate strategically while performing hands-on analyses in a lean environment.
• Experience supporting regulatory interactions and submissions.
• Proficiency with R, SAS, and modern data visualization tools.

Responsibilities

• Lead statistical strategy for all studies, including design, sample size, and endpoint selection.
• Develop SAPs, mock shells, and analysis specifications.
• Ensure accuracy, efficiency, robustness in analysis, interpretation, reporting, and presentation of results.
• Provide statistical oversight for data review, interim analyses, dose-escalation decisions, and safety monitoring.
• Partner cross-functionally with Clinical Development, Clinical Operations, Data Management, Regulatory, and Translational Sciences.
• Guide biomarker, PK/PD, and immunogenicity analyses related to bispecific antibodies.
• Oversee CROs performing statistical programming, analysis, and TLF generation.
• Oversee biostatistical contractors and mentor junior team members.

Skills

Biostatistics leadership

Clinical trial design

Regulatory submissions

CRO management

R

SAS

Data visualization

Education

PhD in Biostatistics

Master’s degree in Biostatistics

Tools

R

SAS

Tableau/Power BI

Job description

The Director, Biostatistics, will serve as the strategic and operational lead for all biostatistical activities across our clinical pipeline. You will be responsible for statistical strategy, analysis planning, vendor oversight, and ensuring high-quality, submission ready statistical outputs for all programs. You will be expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data and multiplicity handling. You will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, execution and evaluation of clinical trials. Reports to the Head of Biometrics.

Key Responsibilities

• Lead statistical strategy for all studies, including study design, sample size calculations, and endpoint selection.
• Develop Statistical Analysis Plans (SAPs), mock shells, and analysis specifications.
• Ensure accuracy, efficiency, robustness in statistical analysis, interpretation, reporting, and presentation of clinical study results
• Provide statistical oversight for clinical data review, interim analyses, doseescalation decisions, and safety monitoring.
• Partner cross functionally with Clinical Development, Clinical Operation, Data Management, Statistical Programming, Regulatory, and Translational Sciences.
• Guide biomarker, PK/PD, and immunogenicity analyses relevant to bispecific antibody mechanisms.
• Oversee CROs performing statistical programming, analysis, and TLF generation.
• Oversee biostatistical contractors and mentor junior team members as needed.
• Support regulatory submissions including briefing documents, IND amendments, DSURs, and future BLA components.
• Provide statistical input into protocols, study designs, and clinical development strategies.

Qualifications:

• PhD or Master’s degree in Biostatistics, Statistics, or related quantitative fields.
• 10+ years of biostatistics experience in biotech/pharma, including direct oversight of clinical trials.
• Experience with bispecific antibodies, biologics, or immunology preferred
• Strong expertise in clinical study design, SAP development, and regulatorygrade statistical outputs.
• Deep knowledge of CDISC, ICHE9, and regulatory expectations.
• Deep knowledge of advanced statistical methods, including innovative trial designs and endpoints, missing data and multiplicity handling.
• Experience managing CROs and statistical programming teams.
• Ability to operate strategically while executing handson analyses in a lean environment.
• Experience supporting regulatory interactions and submissions.
• Proficiency with R, SAS, and modern data visualization tools.