Head of Biometrics and Real World Evidence
Company Name:-
Spark Therapeutics
Job Location:-
Pennsylvania
Job Summary:-
The Head of Biometrics and Real World Evidence is responsible for creating and implementing the strategic direction for biostatistics, real world evidence, programming, data management and eData collection activities across all projects, in all phases of development and ensuring that proper statistical analyses and interpretations are carried out.
S/he will be responsible for developing functional infrastructure and in building the biometrics capabilities at Spark and, in collaboration with the Heads of Clinical Development & Regulatory Affairs, sets or significantly influences the long-term strategic direction for Biometrics in-line with the broader Development strategy.
The Head of BRWE will be a key contributor to the long-term planning for the Development organization and directly accountable for key milestone that support corporate objectives.
Responsibilities
% of Time
Job Function and Description
35%
Develop, implement and drive evolution of Sparks statistics, data management, programming, RWE and eCOA capabilities
Serve as a strategic partner working closely with clinical development and other relevant functional groups in providing statistical input to clinical development plans and trial designs
Serves as the point of escalation for all biometric functions for Asset & Study teams to ensure the timeliness and accuracy of biometric deliverables
Provides support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority meetings (e.
g.
, advisory panels or other meetings)
Presents analyses to internal and external audiences (e.
g.
regulatory agencies, collaborators, investigators, vendors, alliance partners, etc.
)
25%
Responsible for the development of statistical analysis plans/reports/models, to include statistical methodology (including authoring), statistical programming procedures, and production of tables, listings and figures, either directly or through management of CROs
Provides expert statistical review/Q.
C.
and input into statistical deliverables (i.
e.
analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (i.
e.
database de
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