Lead Statistician

Date: Feb 17, 2024

Location: Philadelphia, PA, US, 19104

Company: Spark Therapeutics

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 1-4 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., pre-IND, 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 cross-functional teams.
  • Mentor and lead study level statisticians.
  • Collaborate cross-functionally (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 non-statisticians.
  • 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.
  • 2-3 days on site in Philadelphia, PA

 

Education and Experience Requirements

 

  • PhD in Biostatistics or Statistics with ≥ 4 years of pharmaceutical or CRO industry experience (MS candidates with significant related experience may be considered).
  • Experience in design and reporting of Phase 1-3 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 re-estimation.
  • Extensive SAS and R programming and simulations required.
  • Excellent verbal and written communications skills, strong presentation skills, able to translate statistical concepts to non-statisticians.
  • 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 cross-functional teams leading to successful global regulatory filings and approvals.

 

 

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $130,200 to $195,400.

 

 

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.


Nearest Major Market: Philadelphia