Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. Voyager’s pipeline focuses on severe neurological diseases in need of effective new therapies, including Parkinson’s disease, a monogenic form of ALS called SOD1, Huntington’s disease, Friedreich’s ataxia, neurodegenerative diseases related to defective or excess aggregation of tau protein in the brain including Alzheimer’s disease and other tauopathies, neurodegenerative diseases related to defective or excess aggregation of alpha-synuclein protein in the brain including Parkinson’s disease and other synucleinopathies, and severe, chronic pain. Voyager has strategic collaborations with Sanofi Genzyme, AbbVie and Neurocrine Biosciences. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, Massachusetts.
Biostatisticians play a critical role in the advancement of new medicines at Voyager. The right candidate will partner with clinicians, translational medicine, and other scientists to support drug development in Voyager’s Clinical Development and Translational Medicine Unit. The statistician will support the development of innovative and efficient plans for developing genetic medicines for severe neurological diseases. He/she will be involved in the design, analysis, and reporting of clinical protocols covering early clinical development from first in human through registration. He/she will provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables.
- Collaborate with various scientists in the design, analysis and reporting of laboratory and clinical studies with a focus on innovative trial methodology including seamless and adaptive study design
- Core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality manner.
- Interact with internal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types.
- Leader to bring innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Voyager. Central to this approach is the systematic review of prior information, statistical model building and simulation, utilizing Bayesian methods as appropriate, to design more effective studies.
- Frequently interact with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need.
- Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives.
- Use statistical expertise to influence both internal and external reports and presentations, with the aim to improve the quality of internal decision making and increase our influence on the external environment.
- PhD in statistics or related field with a minimum of 5 years of clinical trial experience in the pharmaceutical industry, or MS in statistics or equivalent with at least 7 years of clinical trial experience in the pharmaceutical industry
- Ideally the candidate’s experience would include exposure to the design and analysis of clinical studies in both early and late stage clinical development. The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems and experience with modeling and simulation in early clinical development and experience in using Bayesian methods to scientific research.
- The preferred candidate will have strong computational skills in R, S-plus, or SAS and other statistical applied software systems. Prior experience providing statistical support to clinical studies in neuroscience or rare diseases is a plus. Must be able to explain statistical techniques and considerations to non-statisticians. Good communication skills and the ability to work collaboratively with the clinical project team are required.
- Knowledge of CDISC
- Strong knowledge of FDA, EMA and ICH guidelines and regulations
- Experience with internal and independent data monitoring committees preferred
- Committed to excellence in Good Clinical Practice
- Experience with partnering with CROs
- High interest/experience in adaptive design, Bayesian methodologies
- Experience in Modelling and Simulation, Pharmacometrics or Patient-Centered Outcome Research would be very desirable
- Help to delineate applicable unmet medical needs, competitive landscape, and desirable target product profiles as part of our team
- Build and foster relationships with the international scientific community. Actively work to recruit strong, relevant partners in collaborators, scientific advisors and other key scientific resources who can help advance the company’s research
- Participate in the creation of a sound intellectual property portfolio.
- Oversee budget, manage CROs, data managers, biostatisticians and make final decisions on operational matters.