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 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.

The Lead Biostatistician is expected to act independently as the statistics subject matter expert for all clinical development programs and studies, including oversight of data management and statistical programming activities, while ensuring adherence to all regulatory requirements.  H/she is responsible for providing broad statistical support and contributing strategically to project decisions, with a focus on clinical planning, study design, protocol development, sample size / power calculations and simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in-trial data quality review, pre-database lock data quality control, supporting development of table / listing / figure templates, programming and production, oversight of contract or CRO resources, as well as preparation, integration and documentation of clinical regulatory submission package, in accordance with CDISC standards. 

The Lead Biostatistician is expected to have an in-depth understanding of advanced statistical methods, including adaptive trial design, missing data and multiplicity handling. She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, execution and evaluation of clinical trials. In addition, she/he will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively with clinician, clinical operations, medical writing, regulatory affairs, information technology and other colleagues, service/technology providers, as well as external drug development agencies or organizations. She/he will have a good understanding and the capacity to sustain the dialog in consultations or advisory board meetings with biostatistical, clinical and regulatory key opinion leaders about clinical study design, execution and evaluation from the statistical perspective.

Responsibilities

  • Extensive collaboration with integrated clinical teams to design studies, develop statistical analysis plans, and draft statistical reports / manuscripts for clinical studies in all phases for CDER, CDRH, and CBER divisions of the FDA, as well as for other global regulatory authorities
  • Provide strategic and statistical input to clinical program and clinical study teams, as well as advisory board or expert meetings
  • Actively contribute to what and how data are collected, be familiar with CDISC data structure, formatting and documentation standards for clinical studies, as well as integrated safety and efficacy datasets
  • Review documents related to clinical data management, including (e)CRFs, EDC, eSource/eCOA/ePRO and data management validation plans and their deployment
  • Prepare randomization specifications and generate or oversee the setup of randomization processes and systems, including for adaptive and enrichment trial designs
  • Plan, program and execute sample size and assumptions calculations and simulations for conventional, adaptive and enrichment trial designs, reflecting the actual methodology planned for the study evaluation, including statistical model, missing data and multiplicity handling, as well as sensitivity analyses
  • Design, develop, modify, document and evaluate the technical data processes, systems and infrastructure to expedite and evaluate analysis and reporting of clinical studies
  • Ensure accuracy, precision, efficiency, robustness in statistical planning, study design, statistical analysis, interpretation, reporting, and presentation of clinical study results
  • Evaluate and interpret clinical trial data, write up reports, prepare slides and present results to internal and external stakeholders including regulatory agencies
  • Assist in drafting and review of clinical study reports and statistical methodology and results sections of documents prepared for scientific communication (i.e., reports, manuscripts, posters, abstracts), including posting of results in public study registries
  • Contribute to the selection, information, oversight and evaluation of expert consultants, contractors, CROs and other partners providing statistical services
  • Participate in multi-disciplinary meetings and teleconferences and provide consulting, interpretive, and analytical support
  • Identify and plan statistical tasks, timelines, resources and account for critical dependencies and resources in order to estimate, agree and ensure that statistical work meets deadline commitments and quality standards in a timely manner
  • Lead projects by managing statistical tasks, resources, timelines and budgets as well as act as point of contact for internal and external teams including consultants, contractors, CROs and other vendors
  • Contribute to the definition and oversight of the setup, methodology, tools decision rules, support and implementation of DSMBs and ability to direct, mentor and develop more junior statisticians and programmers
  • Take an active role in task forces or process-improvement groups and assist in providing guidance related to biostatistics, programming and/or data management
  • Maintain exhaustive program and clinical trial documentation, including design, execution, evaluation, review, QC, tracking information, as well as internal and external communications
  • Perform peer review of other statisticians’ work; Perform QC of analysis datasets, data displays for efficacy and safety variables

Qualifications

  • A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 4 years of relevant clinical biostatistics experience in pharma, biotech or medical device industry -OR- a Master’s degree and a minimum of 8 years of relevant industry experience is required
  • Experience of neuroscience clinical development is highly preferred; Comprehensive knowledge of statistical theory and methods
  • Demonstrated ability to apply statistical, programming and data management knowledge to clinical studies and other supportive tasks
  • Expertise in SAS and R programming for data management, conversion, review and visualization, statistical analysis, tabulation, listing and graphs of clinical trial data
  • Excellent verbal and written communication skills; Leadership and team-ability with effective intercultural competences, diplomacy, negotiation and communication
  • Self-management skills with the ability to take initiatives, develop and evaluate alternative scenarios and options, and present them effectively to the colleagues and leadership of the company
  • Proficiency in MS Word, Excel, and PowerPoint software programs
  • Excellent problem-solving and strategic-thinking skills
  • Sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.)
  • Excellent written and oral communication and presentation skills
  • Ability to identify and address issues proactively in a timely manner
  • Ability to make appropriate, rational and well-justified decisions in ambiguous situations with incomplete or uncertain information; Ability to prioritize tasks and direct team accordingly

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