Magenta Therapeutics a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients by making the process more effective, safer and easier. A culture fueled by an amazing, passionate group of people committed to the idea of “patients first” and making a difference are at the very core of our progress in pursuing this vision.
Our roles don’t dictate our daily activities – every employee is empowered to make an impact, seize opportunity and to develop skills and expertise.
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