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Sr. Biostatistician

Date: Apr 26, 2021

Location: Philadelphia, PA, US

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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

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

 

Primary Duties

This Sr. Biostatistician will provide critical statistical support to Spark’s clinical development.  Key responsibilities will include:

 

  • Provide statistical input to the design, analysis, reporting and interpretation of clinical studies. 
  • Influence clinical development plans, regulatory and commercial strategies. 
  • Build and maintain effective strategic working relationships with internal and external partners to meet business needs. 
  • Identify, develop, and implement novel statistical methodologies in support of gene therapy development. 
  • Work across all phases of development to author/review regulatory documents and develop scientific publications.  
  • Systematic review of prior information, statistical model building and simulation, and utilization of Bayesian methods as appropriate, to design and analyze effective studies. 
  • Collaborate with various scientists in the design, analysis and reporting of laboratory and clinical studies with a focus on innovative methodologies. 
  • Ensure sound quantitative approaches are applied to data collection and analysis with a wide variety of data types. 

 

Responsibilities 

% of Time

Job Function and Description

30%

Provide statistical input to the design, analysis, reporting and interpretation of clinical studies.

30%

Influence clinical development plans, regulatory and commercial strategies.

25%

Collaborate with various scientists in the design, analysis and reporting of laboratory and clinical studies with a focus on innovative methodologies.

15%

Work across all phases of development to author/review regulatory documents and develop scientific publications.

 

Education and Experience Requirements 

    • A Masters or PhD in Statistics/Biostatistics and typically 5+ years of relevant pharmaceutical experience.Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design regulatory requirements relating to clinical development of drugs and biologics
    • BLA/NDA experience including eCTD submissions
    • Working knowledge of major statistical software programs including SAS
    • Knowledge of CDISC requirements for SDTM and ADaM
    • Excellent verbal and written communication skills, and excellent inter-personal skills.
    • The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure.

 

Key Skills, Abilities, and Competencies 

    • Support studies and programs for identified therapeutic area(s) or phase(s) of development.
    • Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
    • Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.
    • Leverage standardization to maximize global data integration and interpretability.
    • Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.
    • Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.
    • Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)
    • Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
    • Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.

 

 

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Nearest Major Market: Philadelphia