Lead Statistician - Philadelphia, United States - Spark Therapeutics

Spark Therapeutics
Spark Therapeutics
Verified Company
Philadelphia, United States

1 month ago

Mark Lane

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Mark Lane

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Description
Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.

We don't follow footsteps. We create the path.


Primary Duties:


The Lead Project Statistician will be responsible for strategic statistical and 'hands on' day to day support for several projects in support of Spark's clinical development programs.

This individual will contribute and collaborate with project teams, develop statistical study designs and statistical analysis plans, conduct exploratory analyses using R/SAS, and support responses to regulatory questions.

This individual will contribute to protocols, data reporting for CSR/DSUR/IB, regulatory activities and safety assessment.


Responsibilities

  • Lead the statistical strategy for projects and participate as a core member on clinical study teams.
  • Be accountable and responsible for the statistical design, analysis plans, reporting (including development of ADaM specifications/datasets) and interpretation of Phase 14 clinical trials including integrated analyses across trials.
  • Initiate, drive and implement novel methods and innovative trial designs.
  • Provide statistical input into protocol and case report form (CRF) development (e.g., trial design, sample size estimation, statistical methods for protocols, edit checks for clinical trial data)
  • Participate in regulatory (e.g., preIND, NDA) activities including authoring of statistical sections and participating in regulatory meetings/written responses.
  • Contribute to planning and execution of exploratory analyses, data visualization and statistical consultation on crossfunctional teams.
  • Mentor and lead study level statisticians.
  • Collaborate crossfunctionally (e.g., data management, programming, safety, clinical, etc.) to ensure timeliness and quality for statistical deliverables.
  • Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings.
  • Interpret and clearly communicate statistical results and concepts to nonstatisticians.
  • Provide statistical support and outputs for conference presentations, manuscripts, CSRs, DMCs, etc.
  • Develop/Write statistical standard operating procedures (SOPs) and input into general standardization efforts (e.g., CDISC, TFLs, eCRFs).
  • Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
  • Monitors program progress and ensures proper resource allocation for successful project deliverables against goals and timelines.
  • 23 days on site in Philadelphia, PA

Education and Experience Requirements
PhD in Biostatistics or Statistics with

  • Experience in design and reporting of Phase 13 clinical trials.
  • Deep and broad statistical training and experience in methodologies such as Mixed Models, Bayesian adaptive designs, Interim Analyses including Futility, Modelling and Simulation methods, and in SAS, R.
  • Experience writing statistical analysis plans and mock TFLs for clinical study reporting.
  • Experience supporting DSURs, IBs and DMCs.
  • Extensive experience reporting clinical studies to CDISC standards.
  • Expertise and experience in ADaM specifications and datasets

Key Skills, Abilities, and Competencies

  • Expertise and experience with Bayesian adaptive designs in early clinical development, Bayesian Go/NoGo decision framework for Stage Gate for End of Phase 2, and sample size reestimation.
  • Extensive SAS and R programming and simulations required.
  • Excellent verbal and written communications skills, strong presentation skills, able to translate statistical concepts to nonstatisticians.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Ability to organize multiple work assignments and establish priorities.
  • Ability to work successfully within crossfunctional teams leading to successful global regulatory filings and approvals.
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