Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.. We are seeking a sophisticated and nuanced Biostatistical Director or Senior Director to lead, develop and implement statistical solutions to optimally support all phases of clinical trials and decision making for Agios' Rare Disease therapeutic area (RGD). The successful candidate will function as the therapeutic area lead Statistician across our RGD clinical development programs and will supervise in-house study level statisticians as well as external CRO resources, with accountability for all biostatistics study deliverables. The role will include key trial statistician responsibilities including statistical design of all phases of trials, authoring of SAPs, and conducting just-in-time analyses and data exploration. Industry experience is required; experience with regulatory filings also strongly preferred.. The successful candidate will have the opportunity to take a leadership role in the Biostatistics function at Agios, but must possess the desire and ability to work with study teams up through and including leadership responsibilities.. Key Responsibilities:. Serve as the lead statistician across clinical development. Ensure that clinical development programs meet scientific, regulatory, and quality requirements programs. Perform management of in-house and/or outsourced biostatisticians/programmers, and mentor these team members as required. Perform trial statistician responsibilities as needed, 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. 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. Serve as a general clinical development and statistical resource at Agios; participate in non-clinical project activities.. Qualifications:. PhD in Biostatistics or related discipline with 9+ years biopharmaceutical industry experience; MS in Biostatistics or related discipline with extensive industry and leadership experience will be considered. Prior experience in a program statistician role (4 years minimum). Prior in-house statistician managent experience (2 years minimum). Experience with Bayesian methods preferred. Experience with regulatory submissions. Proven knowledge and expertise in statistics and its applications to clinical trials. Fluent with statistical software including SAS, R, EAST, Winbugs, Spotfire among others. Ability to work independently. Fluent in English (oral and written). Excellent communication and presentation skills. Team player, with ability to work successfully across functions. Ability to lead and inspire Biometrics teams. Innovative, flexible mindset. Agios Competencies. Drives and Delivers : Executes and Operates to a High Standard and Resourceful. Connect and Relate : Collaborates and Talks Straight. Build and Transform : Improves Continuously and Builds Networks. Lead from Every Chair : Empowers Self and Others and Challenges Self and Others. Agios Pharmaceuticals is a public American pharmaceutical company focused on developing small-molecule anti-cancer therapeutics targeting... Associated topics: bioinformatics, biometrics, biostatistics, data analyst, data science, sas, statistics
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