Associate Director, Biostatistics

Agios Pharmaceuticals Cambridge , MA 02138

Posted 3 months ago

Associate Director, Biostatistics

Agios is seeking an innovative Associate Director for our Biostatistics team. Our statisticians lead, develop and implement statistical solutions to support all phases of clinical trials and influence decisions across our oncology and the rare genetic disorder platforms. The successful candidate will function as an independent program statistician across multiple clinical development programs, and will supervise study level statisticians/programmers at CROs.

Agios Statisticians are accountable for all biostatistics study deliverables and manage key trial responsibilities including: statistical design of all phases of trials, authoring of SAPs, and conducting just-in-time analyses and data exploration. The successful candidate must possess the desire and ability to work with study teams up through and including leadership responsibilities as part of our growing, evolving group.

RESPONSIBILITIES:

  • Serve as the statistical leader and project manager for all biostatistics deliverables across assigned clinical development programs

  • Ensure that clinical development programs (or parts assigned) meet scientific, regulatory, and quality requirements

  • Manage outsourced biostatisticians/programmers, and mentor team members as needed

  • Perform trial statistician responsibilities including attendance of study team meetings, authoring SAPs, reviewing CRFs, design of phase 1-3 and PK studies, review of protocols/amendments, conducting exploratory data analyses, and performing just-in-time analyses

  • Apply innovative statistical approaches to study design, analysis and data exploration methodologies, including Bayesian adaptive methods to dose finding

  • Plan and track study level activities within programs, including resources; ensure CRO timelines and objectives are met

  • Help establish and maintain Agios data standards, within and across programs (e.g. standardization of CRFs, outputs, SAPs)

  • Plan and manage submission activities, like SCS, SCE, briefing books.

  • Serve as a general clinical development and statistical resource at Agios; participate in non-clinical project activities

REQUIRED QUALIFICATIONS:

  • PhD in Biostatistics and 5+ years biopharmaceutical industry experience as a biostatistician OR;

  • Masters Degree in Biostatistics and 10+ years biopharmaceutical industry experience as a biostatistician

  • Fluent in English (oral and written)

  • Prior Experience with regulatory submissions

  • Proven knowledge and expertise in statistics and its applications to clinical trials

  • Fluent with statistical software including SAS, R, EAST, among others

  • Proven ability to work independently

  • Excellent communication and presentation skills

  • Team player, with ability to work successfully across functions

  • Ability to lead and inspire Biometrics teams; previous experience managing contractors

  • Innovative, flexible mindset

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Associate Director, Biostatistics

Agios Pharmaceuticals