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Senior Principal/Associate Director - Biostatistician

Posted on Apr 6, 2021 by Agios Pharmaceuticals

Cambridge, MA 02138
Research
Immediate Start
Annual Salary
Full-Time


Agios has a differentiated portfolio, unparalleled expertise in cellular metabolism, and a committed team that will continue to drive the company's mission to make a difference for patients with hematologic malignances, solid tumors, and rare genetic diseases. As our portfolio continues to expand, we are opening new positions within the Biometrics department. We are seeking both junior and experienced biostatisticians with a desire to learn and contribute to different aspects and phases of drug development, and motivated by the opportunity to join a knowledge-diverse team of statisticians and statistical programmers with a curiosity-driven and nurturing culture. Your work will directly contribute to the continued realization of the Agios mission for years to come.


The successful candidate will function as study statistician or lead statistician for an indication and be responsible for study- or drug-program-level statistical deliverables including protocol development, writing of statistical analyses plans, developing Data Monitoring Committee charters, contributing to study-start up activities, performing statistical analysis, writing reports, presenting results summarizing findings, and contributing to publications of results. The successful candidate will also participate in regulatory submissions and response to regulatory queries.


Position will be filled at level commensurate with experience.


Key Responsibilities:


Provide scientifically rigorous statistical input to protocols, statistical analysis plans, interpretation of statistical results, and scientific publications.
Accountable for study-level or submission-level statistical deliverables on assigned projects, including timeliness and quality of deliverables.
Develop effective collaborations with others within the clinical team
Ensure that all study or indication-level statistical activities are conducted in compliance with relevant regulatory requirements and Agios standards.
Help establish and maintain biometrics standards at Agios
Serve as a general clinical development and statistical resource at Agios


Qualifications:


Sr Principle Statistician: PhD in Biostatistics or related discipline with 3+ years biopharmaceutical industry experience; MS in Biostatistics or related discipline with 6+ years biopharmaceutical industry experience
Associated Director of Biostatistics: PhD in Biostatistics or related discipline with 6+ years biopharmaceutical industry experience; MS in Biostatistics or related discipline 9+years biopharmaceutical industry experience
Experience with regulatory submissions required for Associate Director position
Fluent with statistical software including SAS, R, EAST, and nQuery
Excellent oral and written communication skills




Reference: 1152693993

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