Principal Statistical Programmer, Biometrics

Principal Statistical Programmer, Biometrics

Who we are:

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate.

Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.

Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit  and follow Agios on Linked In and X . The impact you will make:
Agios Pharmaceuticals is seeking a dynamic Principal Statistical Programmer to join our growing Biometrics team. We are looking for someone who is passionate about this work and motivated by our mission to serve patient communities. In this role, you will lead study-level statistical programming deliverables, including developing programming specifications and programs for SDTMs and analysis datasets in accordance with Agios, CDISC, and study- or submission-specific standards;

develop programs for tables, listings, and figures based on Agios standards or study-specific/submission-specific requirements, reviewing CRFs and creating SDTM-annotated CRFs; reviewing statistical analysis plans, analysis datasets, and outputs; performing hands-on programming; and reviewing CRO deliverables. Candidate must have a strong working knowledge of CDISC requirements and Pinnacle 21.

What you will do:

Develop and/or validate programming specifications and programs to generate SDTMs and analysis datasets, using Agios, CDISC standards and study-specific/submission-specific requirements. Develop and/or validate specifications and programs to generate tables, listings, and figures based on Agios standards and 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. Support establishment and maintenance of statistical programming standards ure 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.

What you bring:

MS or equivalent degree with 7+ years biopharmaceutical industry experience 3+ years project management experience as a statistical programmer preferred 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 in open-source languages like Python or R preferred 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.…