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.
% 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
Internal Number: 1664
About Spark Therapeutics
At Spark Therapeutics, we don’t follow footsteps.
We create the path. We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our mission is seemingly impossible to others, but not to us: Challenge the inevitability of genetic disease by discovering, developing and delivering treatments in ways unimaginable – until now.
Since our founding, we have been committed to bringing a wide range of expertise to build a fully integrated gene therapy company focused on inherited retinal diseases (IRDs), neurodegenerative diseases, as well as diseases that can be addressed by targeting the liver, such as hemophilia. We are seeking talented individuals with diverse experiences, abilities and interests who have the curiosity, courage and drive to reimagine a new health care paradigm.
Join us on a journey through uncharted territory – seeking to bring gene therapy for genetic diseases to people worldwide. The resilience of the people we serve is our inspiration to break barriers, as we strive to turn genes into medicine for those with inherited diseases. Spark is a member of the Roche Group.
Know tha...t working at Spark Therapeutics is not just another job; it is a once-in-a-lifetime opportunity. We embrace the challenges before us and the uncertainty inherent in them. Ultimately, we are working to create a world free of genetic disease.