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 Senior Statistician will continue the mission of embedding statistical thinking into the Research and Technology organization. They will collaborate with scientists across all areas to design, analyze, visualize, and report results that contribute 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, quality control, manufacturing, CMC regulatory and scientific facilities. The incumbent is also responsible for collaborating with other statisticians to support team infrastructure and interact with regulatory authorities as needed.
Responsibilities
• Point of contact in supporting statistical approaches for cross-functional teams. Participate in the planning of associated experimental designs, analyses, and interpretation of results.
• Advanced skills in at least one statistical analysis and visualization software package (e.g., R, JMP, SAS)
• Application of statistical methodologies over a spectrum of R&T projects (e.g., imaging analysis studies, process characterization studies, multivariate process optimization, CPV, specification setting, comparability studies, shelf-life analysis, control charting and process capability analysis, etc.)
• Develop applications, tools, and methodological best practices for statistical analyses in collaboration with other members of non-clinical statistics.
• Contribute to development of reports for regulatory submissions and support health authority inspections. Conduct interactions with regulatory authorities as needed to support statistical approaches for analyses provided in submissions, information requests, or post-approval filings.
• Assist in preparation of statistical courses and provide training to scientists.
Education and Experience Requirements
• Typically, PhD or Master’s degree in statistics with 3-5 years of relevant experience in applying statistical methodologies.
• Experience in pharmaceutical development and statistical consulting.
• Proficiency in statistical and visualization software with R, JMP, and/or SAS.
• Proven experience in direct interactions with regulatory agencies is preferred.
Key Skills, Abilities, and Competencies
• In-depth knowledge of experimental design and analysis, variance components estimation, mixed models, and multiple industrial statistical problem-solving techniques.
• In-depth knowledge of statistical methodologies as applied to meeting global regulatory requirements.
• Excellent written and verbal communication skills to report and present results to internal stakeholders as well as external collaborators and agencies.
• Knowledge and understanding of application of standard business procedures (SOPs, guidance documents, etc.)
• Understanding of CMC, bioanalytical and/or pre-clinical research aspects of drug development.
• Proven success in collaborating with key stakeholders across different disciplines.
• Experience in gene therapy discovery and development preferred.
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 $97,300 to $146,000.
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.
Location: Philadelphia, PA
Posted: Aug. 15, 2024, 6:13 a.m.
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