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Description:
WHO WE ARE:
Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
WORK LOCATION:
Location Agnostic: Work location for this role is based on employee’s individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
Responsibilities:
- Responsible for analysis data set preparation efforts within the Pharmacometrics team and responsible for conducting statistical non-compartment analysis (NCA) supporting all phases of clinical studies.
- Conduct NCA statistical analysis using Phoenix WinNonlin.
- Perform data quality check on NCA analysis results generated by internal team members.
- Write SOPs on Phoenix WinNonlin and Integral workflow and be responsible for periodic review and revision of these SOPs.
- Generate customized analysis ready data sets for PK and PD analysis supporting preclinical and clinical programs, including: PK and PK-PD data sets for non-compartment (NCA) analysis; NONMEM data sets for translational PK-PD modeling; and NONMEM data sets for population PK, PK-PD, and exposure-response analyses.
- Generate summary data tables and figures for data exploration/visualization, to facilitate downstream pharmacometrics modeling work.
- Develop and maintain internal templates of summary tables and figures related to typical pharmacometrics analysis.
- Conduct quality check on compiled PK, PK-PD, and NONMEM datasets generated by external vendors or internal team members.
- Work with project data manager and biometrics lead to coordinate access to source data (SDTM, ADaM) and resolve data related issues.
- Utilize the following tools/technologies: SAS, R, Phoenix WinNonlin, and Pinnacle 21.
- Position allows working from home anywhere in the United States; HQ located at 88 Sidney St., Cambridge, MA 02139.