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 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 Project Lead will act as the lead statistician for more than one projects, contribute and collaborate on project teams, develop the statistical design/strategy and statistical analysis plans, conduct exploratory analyses using R/SAS, and support responses to regulatory questions. This role will contribute to Protocols, data reporting (TFLS) for CSR/DSUR/IB reporting, regulatory activities and safety assessment. This role will be a core member of the Study and Clinical Project teams, key partner with R&D colleagues and collaborate across Biometrics and RWE functions to progress Spark’s portfolio of clinical stage gene therapies.
Responsibilities
Job Function and Description

Lead the statistical strategy for projects and participate as a core member on clinical project 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.
Collabo

Remote

Link:-

Click Here For More Details