Associate Director, Biostatistics

📋 Description

• • Join BridgeBio Pharma, an innovative biopharmaceutical company pioneering a "moneyball for biotech" approach to accelerate the development of life-changing medicines for patients with unmet needs, particularly in rare diseases.
• • As an Associate Director, Biostatistics, you will play a pivotal role within Eidos Therapeutics, a BridgeBio affiliate focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
• • This remote U.S.-based position offers a unique opportunity to contribute to critical Medical Affairs activities, leveraging your statistical expertise to shape medical strategy, publications, and external engagements.
• • You will be instrumental in the design, execution, interpretation, and communication of statistical analyses that drive informed medical decision-making, demonstrate health outcomes, and facilitate scientific exchange.
• • A key aspect of this role involves collaborating with internal cross-functional teams, including Medical Affairs, Health Economics and Outcomes Research (HEOR), and Clinical Development, to ensure alignment of statistical activities with broader company objectives.
• • You will also be responsible for managing external partners, specifically Contract Research Organizations (CROs), overseeing their biostatisticians and statistical programmers to ensure the accurate and timely delivery of analysis files and statistical analyses.
• • Your responsibilities will extend to providing crucial statistical input for medical publications, scientific congress presentations, and external collaborations, ensuring that all statistical methodologies applied are robust and align with current scientific and regulatory standards.
• • You will apply sophisticated statistical methodologies to support key areas such as generating medical insights, demonstrating therapeutic value, monitoring patient safety, and managing the lifecycle of our medicines.
• • A core function of this role is to ensure the highest quality of statistical deliverables, meeting rigorous scientific and regulatory expectations.
• • You will translate complex statistical concepts into clear, actionable insights for both medical and scientific stakeholders, fostering a shared understanding and facilitating data-driven discussions.
• • Staying abreast of evolving statistical methods, emerging data sources, and regulatory expectations, particularly concerning real-world evidence (RWE), will be essential for success in this role.
• • You will provide expert oversight to CROs and vendors, establishing clear procedures, setting expectations for deliverables and timelines, and ensuring the accuracy and punctuality of their contributions.
• • This role requires a proactive approach to problem-solving, with the ability to independently identify issues, investigate root causes, and formulate effective solutions.
• • You will be expected to communicate complex statistical findings effectively to diverse audiences, including those with non-technical backgrounds.
• • The position encourages the exploration and ethical application of AI-powered tools and technologies to enhance clarity, speed, and quality in statistical work.
• • While this is a remote role, occasional visits to the San Francisco, CA office will be required for team collaboration and strategic meetings (approximately quarterly or as needed).
• • BridgeBio's unique model fosters an environment where scientific expertise and innovation are paramount, allowing for rapid advancement of promising research.
• • You will be part of a dynamic and fast-paced environment, contributing to the development of therapies for serious unmet medical needs.
• • This role is an excellent opportunity for a seasoned biostatistician to make a significant impact on patient lives by contributing to the strategic direction and execution of medical affairs initiatives.
• • You will have the chance to work alongside respected minds in the biopharmaceutical industry, pushing boundaries and redefining the future of medicine.
• • Embrace the BridgeBio ethos of asking "why not?" and contribute to a culture that values curiosity, experimentation, and bold scientific inquiry.
• • Your work will directly influence the understanding and communication of clinical data, supporting the successful progression of our therapeutic candidates.
• • You will be a key contributor to ensuring the scientific rigor and statistical validity of all medical affairs-related data analyses and communications.
• • This role offers a blend of strategic input, hands-on analysis oversight, and cross-functional collaboration, providing a comprehensive and rewarding career experience.
• • You will be empowered to take ownership of statistical aspects of medical affairs projects, from initial planning through to final reporting and dissemination.
• • Contribute to the value demonstration of our assets through robust statistical evidence generation and interpretation.
• • Support the ongoing safety monitoring of our products by providing timely and accurate statistical assessments.
• • Engage with the scientific community by presenting data and insights derived from statistical analyses.
• • This position is ideal for an individual who thrives in a challenging yet supportive environment, driven by a passion for science and a commitment to patient well-being.