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Lead Statistician

Date: Mar 23, 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

 

The Lead Statistician will continue the mission of embedding statistical thinking into the Research and Technology organization by collaborating with scientists in all areas to design, analyze, visualize and report data contributing to the advancement of products from target identification through regulatory approval and commercialization.  The role is responsible for providing statistics support across both the research and technology organizations with a focus on immunogenicity assays, animal studies, process development, analytical development, MS&T, quality control, manufacturing, CMC regulatory and scientific facilities. He/she is also responsible for working with the rest of the data science team to support infrastructure (e.g. data capture and analysis software, developing SOPs) and interacting with regulatory authorities.

 

 

 

Responsibilities

 

% of Time

 

Job Function and Description

 

25

Primary point of contact for supporting all statistical approaches for these cross functional teams. Participate in the planning/design of associated experimental designs and analyses.

60

Perform statistical analysis and visualization using statistical software (e.g. JMP, SAS, R) for various projects (e.g. imaging analysis studies, process characterization, multivariate modeling, CPV, specification setting, comparability studies, shelf life analysis, etc.) Develop best practices and SOP for statistical analyses in collaboration with other members of the data science team.

15

Help develop reports for regulatory submissions and supports HA inspections. Have direct interaction with Regulatory Authorities as needed to support statistical approaches for analyses provided in submissions, IRs or post approval filing.

 

 

 

Education and Experience Requirements

 

  • MS or Ph.D. in Statistics, or a related field

•    Minimum 5+ years’ experience in pharmaceutical development and applied statistics/statistical consulting

  • Proficiency in statistical and visualization software such as JMP, R, Spotfire

•     Successful direct experience interacting with regulatory agencies required

  • Minimal travel as nationally and internationally required

 

 

Key Skills, Abilities, and Competencies

 

 

  • In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, SOPs, etc.)
  • In-depth knowledge of statistical methodology and global regulatory requirements,
  • Preferred expertise in gene therapy discovery and development
  • Understanding of commercial aspects of drug development
  • In-depth knowledge of experimental design and analysis, variance components, and multiple industrial statistical problem-solving techniques
  • Proven success in collaborating with key stake holders across different disciplines
  • Excellent communication skills including technical, scientific, and regulatory writing

 

#LI-JW1

 

 

 


Nearest Major Market: Philadelphia