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 rare 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.

WHAT YOU BRING:

• MS or equivalent degree with:
• 7+ years biopharmaceutical industry experience
• 3+ years project management experience as a statistical programmer
• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment
• Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures
• Hands-on experience on SDTM mapping from various data sources
• Knowledge of clinical database design, specifically electronic data capture using Rave, Veeva, and Medidata
• Experience supporting electronic submissions in the eCTD format
• Excellent oral and written communication skills
• Experience with Real World Data a plus
  Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

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.

• Provides technical and project management guidance in SAS programs and applications designed to analyze and report clinical trial data and for electronic submissions of data in CDlSC format.
• Develop or validate programming specifications and programs to generate SDTMs and analysis datasets, using Agios or CDISC standards or study-specific/submission-specific requirements.
• Develop or validate specifications and programs to generate tables, listings, and figures based on Agios standards or study-specific/submission-specific requirements.
• Create SDTM-annotated CRFs
• Accountable for study-level statistical programming deliverables on assigned projects, including timeliness and quality of deliverables.
• Review statistical analyses plans and case report forms.
• Ensure documentation is maintained to the standard required according to CDISC-compliant submissions and is acceptable for audit.
• Help establish and maintain statistical programming standards at Agios.
• Ensure that all study-level statistical programming activities are conducted in compliance with relevant regulatory requirements, Agios SOPs and Agios standards.
• Serve as a general statistical programming resource at Agios including representation in cross-functional teams working on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies.