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Director Biostatistician at Asahi Kasei Therapeutics
Asahi Kasei Therapeutics
Source: Arbetsformedlingen Platsbanken · original listing ↗
Posted today
About this role
About AKTX Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. AKTX is a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon their strong heritage of scientific innovation, AKTX aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions. The Asahi Kasei Group operates with a commitment of creating for tomorrow. Their business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. AKTX is looking for candidates that offer a fresh perspective and a variety of skills to help them achieve their commitment. AKTX’s Mission Pioneering innovation to continue addressing unmet medical needs, now and into the future AKTX’s Vision Positively impacting health by expanding therapeutic options that improve the lives of patients around the world AKTX’s Values Agility, Integrity, Innovation, Expertise and Accountability Diversity, Equity & Inclusion At Asahi Kasei Therapeutics, they believe that diverse perspectives strengthen innovation and help them better serve patients, colleagues, and communities around the world. They are committed to creating an inclusive workplace where everyone is treated with dignity, respect, and fairness and where all employees can contribute and succeed. AKTX is proud to be an equal opportunity employer and welcome applications from qualified candidates regardless of race, ethnicity, nationality, religion, sex, age, disability, sexual orientation, gender identity, or any other characteristic protected by applicable law. About the position as Director Biostatistician As Director Biostatistician, you will be the strategic statistical lead for clinical development programs, responsible for statistical rigor, consistency and quality across all studies within each program. Partnering closely with cross-functional leaders, you will help shape development strategy and guide study designs, as well as recommend the methodologies, estimands and endpoints that best support program objectives. The role also includes overseeing statistical deliverables from internal and external partners, providing clear direction for outsourced work and acting as the escalation point for complex statistical issues. In addition, you will contribute to integrated database planning and, where applicable, the use of external and real-world data, while anticipating data needs for interim analyses, adaptive trials and regulatory interactions. The analyses you oversee will underpin regulatory strategy, publications, safety evaluations and internal decision-making. When engaging with health authorities, you will act as the statistical representative, preparing responses to their questions and attending regulatory meetings in compliance with ICH guidelines and best practices in clinical statistics. Within cross-functional teams, safety review committees and governance meetings, you will translate complex statistical concepts into clear, actionable insights for non-statisticians. Key responsibilities include: Provide strategic input into clinical development plans, target product profiles, and overall program strategy. Advise on quantitative decision making, including go/no go criteria, dose selection, and adaptive design strategies. Collaborate with Clinical Development to design scientifically sound and efficient clinical trials across phases (First-in-Human through registration) Provide oversight and review of statistical sections of protocols, SAPs, and mock TLFs for individual studies. Oversee statistical and programming activities conducted by CROs and external vendors across all studies in the program. Work with Data Management to ensure data collection standards, CDISC compliance, and data structures are optimized for cross study analysis. Provide clear interpretation and communication of statistical results to clinical, regulatory, and senior leadership stakeholders. Lead statistical components of regulatory submissions (e.g., IND, CTA, BLA, MAA). Provide mentorship and guidance to study statisticians and junior team members About you You have the ability to influence senior stakeholders and drive strategic decisions, and you have a strong collaboration mindset with high attention to scientific and operational quality. You are comfortable with a hands-on role, stepping in as a subject matter expert where needed and you lead with clarity, integrity and accountability. You work well across functions, locations and cultures. Requirements: MSc or PhD in Biostatistics or Statistics Significant experience (7+ years) in clinical trial statistics within biotech/pharma. Proven track record of leading statistical activities across multiple programs. Strong working knowledge of regulatory guidelines (ICH, FDA, EMA) and statistical principles in drug development. Expertise in SAS; familiarity with R is beneficial. Excellent communication, leadership, and problem-solving skills. Ability to balance hands-on work with strategic program oversight Preferred qualifications: Demonstrated ability to manage CROs and external statistical partners. Experience with adaptive or innovative designs. Exposure to early-stage development or rare/complex diseases. Experience collaborating with Medical Affairs What AKTX offers Make an Impact Contribute to therapies that improve the lives of patients around the world. Build Something New Help shape the future of Asahi Kasei Therapeutics as they bring together expertise, people, and capabilities into one global organization. One Global Team Work alongside colleagues across Europe, the United States, and Japan in a collaborative and inclusive environment. Grow With AKTX Enjoy opportunities for development, flexible working arrangements, and competitive local benefits.