Oruka Therapeutics

Director

• Drive statistical execution for assigned programs, contributing to study design, protocol development, and statistical analysis planning
• Manage biostatistics timelines and deliverables, communicating resource constraints and risks
• Author and critically review protocol statistical sections, statistical analysis plans, clinical study reports, publications, and other study-level documents
• Provide statistical input for data management and programming deliverables, including data collection tools and analysis datasets
• Develop statistical programs for ad-hoc analyses, manuscripts, and presentations
• Review scientific reports and publications for accurate and appropriate data presentation
• Oversee CRO biostatistics vendors, including timelines and deliverables
• Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards
• Serve as lead biostatistician for multiple Phase I to IV clinical studies and provide statistical leadership for clinical development programs

Associate Director – Biostatistics

• Lead statistical strategy for clinical development programs, including study design, protocol development, and statistical analysis planning
• Plan and track biostatistics timelines, deliverables, and resources for assigned projects
• Proactively communicate resource needs, constraints, and risks
• Independently author and/or review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents
• Provide statistical input for data management and programming deliverables, including data collection tools and analysis datasets
• Develop statistical programs for ad-hoc analyses, manuscripts, and presentations
• Critically review scientific reports and publications for appropriate and accurate data presentation
• Write statistical sections of regulatory documents and collaborate with Clinical and Regulatory teams
• Participate in assessment, selection, and oversight of CROs
• Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards
• Represent the Biostatistics function at internal and external meetings

Director of Biostatistics

Medical Director

• Support development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversee clinical trials at study sites for protocol and GCP adherence
• Review and interpret clinical data to assess investigational drug safety and efficacy
• Author and contribute to clinical and non-clinical development documents, including Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports
• Provide medical expertise on the therapeutic area, disease state, and potential drug effects
• Identify and analyze safety concerns and adverse events and make recommendations
• Stay current with relevant medical literature and clinical trial methodologies
• Contribute medical expertise to external collaborator interactions
• Collaborate with clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical, and project management teams
• Present clinical data to internal and external stakeholders
• Contribute to overall clinical development strategy
• Identify critical clinical development milestones and help drive timelines
• Lead clinical contributions for clinical study reports, clinical documents, and regulatory submissions
• May oversee Clinical Scientists working on the same or other programs

Medical Director – Clinical Development

• Develop and lead product safety surveillance strategies
• Identify emerging clinical safety issues and recommend risk-mitigation measures
• Conduct or oversee routine and ad hoc safety-data reviews and monitor safety signals
• Lead aggregate safety reviews and chair internal safety governance committees
• Plan, interpret, prepare, and present safety-data analyses and summaries
• Build relationships with clinical study teams, safety vendors, and business partners
• Oversee expedited safety reporting, including medical review of ICSRs, SUSARs, and other reportable safety events
• Ensure medical follow-up and consistent assessment of individual safety cases
• Review clinical-trial safety data and provide medical safety guidance
• Lead aggregate reporting and prepare regulatory documents, including Investigator's Brochures, DSURs, and Risk Management Plans
• Provide safety input into clinical development plans, protocols, consent forms, case report forms, statistical analysis plans, data-monitoring plans, and clinical study reports
• Represent Pharmacovigilance in meetings with the FDA and other global regulatory authorities
• Maintain compliance with global pharmacovigilance regulations, SOPs, and internal guidelines
• Build and improve Oruka’s pharmacovigilance system and infrastructure
• Oversee vendors supporting case processing, safety-database management, aggregate reporting, and literature surveillance
• Monitor vendor quality and performance and resolve issues
• Provide safety leadership for independent data monitoring and adjudication committees
• Support inspection readiness and represent Pharmacovigilance during inspections, audits, and due-diligence activities

Senior Medical Director, Pharmacovigilance and Safety

Scientist

• Collect, review, and analyze adverse event reports from clinical trials to identify potential safety signals
• Support quality control review of individual case safety reports (ICSRs)
• Assist with ongoing safety monitoring, data reconciliation, and quality checks
• Support safety data management, including case processing, follow-up, and adverse event coding
• Assess clinical safety data and document adverse events and emerging safety concerns
• Contribute to risk-benefit analyses and risk mitigation strategies
• Prepare and review DSURs, dRMPs, clinical trial protocol sections, investigator brochures, and regulatory submissions
• Conduct literature reviews and safety signal assessments
• Collaborate with clinical operations, regulatory affairs, medical affairs, data management, bioinformatics, and project management teams
• Support pharmacovigilance and CRO vendor communication and oversight
• Support project management of aggregate reports, safety team meetings, and signal evaluations
• Work with the Senior Medical Director, Pharmacovigilance and Safety, to execute pharmacovigilance strategies

Pharmacovigilance Scientist

Clinical Research

• Contribute to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Monitor clinical trial data at study sites to ensure adherence to protocols and GCP guidelines
• Perform data review, reconciliation and standardization to ensure high-quality outputs
• Review clinical data to support assessment of investigational drug safety and efficacy
• Support development of clinical documents, including Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports
• Maintain knowledge of the therapeutic area, disease state, and potential drug effects
• Assess clinical data to identify and analyze safety concerns and adverse events
• Stay current with relevant medical literature and clinical trial methodologies
• Conduct literature reviews for focused scientific questions or documentation
• Collaborate with clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical, and project management teams
• Work closely with the Medical Director, Clinical Development, to execute key tasks

Clinical Scientist, Clinical Development

Manager

• Lead statistical programming activities for multiple clinical trials within a program or complete development program
• Ensure timely, high-quality, compliant development and validation of statistical programming deliverables
• Maintain audit readiness and accuracy of statistical analysis results
• Produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publications, and ad-hoc analyses
• Write specifications for programming requirements
• Oversee CRO SAS programming and review activities, progress, quality, and timelines
• Collaborate with Data Management, Biostatistics, clinical development, and cross-functional teams
• Develop and review TFL shells, SDTM, and ADaM specifications
• Identify issues and develop global tools, macros, or graphical user interface applications
• Maintain advanced knowledge of SAS and industry requirements including CDISC, eCTD, and Define.xml
• Represent statistical programming in audits, inspections, and Health Authority meetings
• Provide technical recommendations and thought leadership
• Adhere to FDA regulations, company SOPs/WIs, and department guidelines