Reporting to the VP, Clinical Development Operations, this important position will provide technical leadership and strategic biometrics input to Magenta’s development programs. We are looking for an experienced leader who can lead the development and implementation of statistical solutions to optimally support all decision making for Magenta’s clinical trials. This critical role will lead Biostatistics and Programming across all clinical programs and/or NDA activities, to help grow and evolve the in-house and outsourced Biometrics functions.
This role will actively support clinical development programs by informing and aligning with leaders across the organization in clinical development, data management, medical writing, clinical operations, regulatory affairs, and translational science to advance drug candidates under development. Leadership experience, demonstrated technical skills, knowledge of innovative methods, knowledge of regulatory requirements, and hands-on experience with NDA/MAA submissions required. Rare Disease experience is preferred.
You are perfect for this role if you are engaged to make an impact through:
Serving as lead statistician for all clinical studies; manage and oversee biostatistics consultants as needed.
Providing strategic and technical guidance, innovative statistical approaches and expertise to define the right questions to be answered in the design of clinical trials, planning of submissions, post-submission strategies, preparations and defenses.
Driving innovative approaches to study design, analysis and data exploration methodologies.
Responsible for oversight of the statistical integrity of studies
Responsible for the oversight of CRO statistical activities.
Exercising leadership within functional areas to grow, develop and mentor teams. Strategically augment internal resources with vendor selection, optimization and management.
Ensuring that clinical development programs meet scientific, regulatory, and quality requirements
Performing programming validation for key derived datasets as required and oversees quality control efforts for external data presentations
Contributing to the writing of internal reports and scientific publications in the areas of methods development and clinical research.
Supporting communications with regulatory authorities
Supporting the communication of study results within Magenta and to key external stakeholders (i.e. advisory members, Board of Directors, potential partners and/or investors, regulatory authorities).
Leading initiatives to improve understanding and application of statistical methods
Other duties as assigned.
Strong insight into the business needs; seeks out areas where statistics adds most value to maximize success of our compounds.
Contributes to scientific articles.
We would be thrilled if you brought the following with you:
PhD. in statistics or related discipline with at least 10+ years of experience in the pharmaceutical or biotech industry
Experience in NDAs, MAAs, BLAS, or other regulatory submissions required
Experience in representing sponsors in meetings with health authorities.
Knowledge of FDA, EMA and ICH regulations and guidelines
Fluent with statistical software including SAS, Prism among others.
Experience with CDISC, including SDTM, ADaM, CDASH.
Experience in clinical development of all phases, with a strong understanding of the underlying science and knowledge of existing therapies Demonstrated ability and experience in the design, analysis and reporting of clinical trials
In-depth knowledge of statistical methods for clinical trials
Ability to competently manage multiple competing priorities, adapting as needs change. Must be comfortable working in a quick-paced environment.
Ability to concurrently lead statistical efforts for multiple studies
Strong communication skills and ability to work with cross-functional study teams
Strong organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner
Successful leaders and contributors within Magenta are:
Driven. You will be focused on the achievement of Magenta’s mission and major corporate goals.
Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way
Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders
Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company
A role model for the company’s cultural pillars; Courage, Commitment & Excellence
Internal Number: 2061
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease.
Magenta’s comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact and pursuing progress for the patients we seek to serve.