Senior Director, Biostatistics at Cytokinetics in San Francisco, CA

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on late phase and post-marketing studies. Sets direction for statistical contributions to real world evidence generation. Develops and/or applies sound statistical methodologies to meet key project objectives, with special focus on Phase 3 and observational studies. Partners with clinical research and medical affairs to generate evidence for regulators, providers and payers. Recruits, develops, and supervises project statisticians. Takes a leadership role in developing and implementing biostatistics department policies, standards, practices, and work-instructions in coordination with other senior leaders. Conceptualizes and implements initiatives for process improvement and or standardization for biostatistics activities and deliverables. Provides strategic statistical guidance to anticipate challenges, mitigate risk, and ensure project success. Manages timelines, deliverables, and budgets of contract research organizations. Essential Duties and Responsibilities Provide strategic input on Cytokinetics development programs Provides critical input on clinical development plans, including post-marketing evidence generation and safety signal seeking. Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives Provide technical oversight of the statistical design, conduct, and analysis of late phase clinical trials and real-world data studies including safety evaluation, Write and review protocols for soundness of trial design. Write and review statistical analysis plans and case report forms. Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets. Build strong relationships both within and outside biostatistics Direct management and supervision of biostatisticians by providing guidance to group members or teams based on organizational goals and company policy, with responsibility for results, costs and resourcing. Education/Experience: MS/MA degree or PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of clinical trials experience Preferred qualifications Experience working on clinical trials in cardiovascular or neuromuscular diseases Experience designing and analyzing observational studies Experience managing multiple statisticians. Has led phase 3 and phase 4 studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses. Knowledge of CDISC standards. Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines. Experience interacting directly with FDA and/or EU Authorities preferred. Knowledge/Skills Strong people management and interpersonal skills Strong communication and collaboration skills Comprehensive and detailed knowledge of statistical experimental designs, analyses, and clinical trial requirements, Excellent knowledge of FDA/EU/ICH statistical guidelines. Has functional understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs, and drug safety. Project management and contract negotiation with outside vendors. Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways. Develops technical and/or business solutions