Braveheart Bio

Software Engineer

• Oversee CRO programming activities, including SDTM, ADaM, TFLs, define.xml, reviewer’s guides, and other clinical study or submission deliverables.
• Review CRO programming plans, specifications, datasets, outputs, QC documentation, issue logs, and submission packages.
• Ensure programming deliverables are accurate, traceable, reproducible, and compliant with CDISC standards and FDA/EMA expectations.
• Serve as the internal programming lead for FDA, EMA, and other regulatory submissions, including support for health authority questions and ad hoc analyses.
• Support ongoing study monitoring by reviewing safety, efficacy, DMC, interim analysis, patient profile, and data review outputs prepared by the CRO.
• Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.
• Work closely with Biostatistics, Clinical Operations, Regulatory, Safety, Data Management, CROs, vendors, and external partners to align timelines, deliverables, standards, and responsibilities.
• Coordinate with alliance or development partners on programming-related deliverables, review comments, issue resolution, and submission-readiness activities.
• Track CRO performance, identify programming risks, resolve issues, and ensure timely delivery of high-quality outputs.
• Provide programming input into protocols, SAPs, data standards, TFL shells, DMC charters, submission plans, and regulatory response strategies.

Senior Principal Programmer

Vice President

• Provide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III execution
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth.

Vice President, Biometrics

Clinical Research

• Serve as the study lead for one or more global clinical trials, overseeing day-to-day execution from start-up through close-out
• Partner closely with the Clinical Operations study leads on key decisions by providing recommendations, proactively identifying risks, and escalating critical issues with proposed mitigation strategies
• Drive study timelines, deliverables, and operational plans, ensuring alignment with overall program strategy
• Oversee and support regional study execution, including site selection strategy, site start-up, and study progress
• Ensure inspection readiness and compliance with GCP, SOPs, and regulatory requirements
• Mentor and provide day-to-day guidance to CTMs, CTMAs, and other junior team members

Senior Principal Programmer

Vice President, Biometrics

Senior Clinical Trial Manager