Principal Statistical Programmer, Biometrics
The Role
Agios Pharmaceuticals is seeking a dynamic Principal Statistical Programmer to join our growing Biometrics team. This role is part of a team that develops innovative medicines to serve patient communities.
Responsibilities
Develop and/or validate programming specifications and programs to generate SDTMs and analysis datasets, using Agios, CDISC 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 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.
Qualifications
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
What You Bring
Strong working knowledge of CDISC requirements and Pinnacle 21
Benefits
Deliberate Development. Your professional growth as one of our top priorities.
Flexibility. We’re all about individual needs.
Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
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.