Associate Director, Statistical Programming
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.
The impact you will make:
Agios Pharmaceuticals is searching for a dynamic AD, Statistical Programming to join our growing Biometrics team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The successful candidate will function as study statistical programmer or lead statistical programmer for an indication and be responsible for study- or drug-program-level statistical programming deliverables including development of programming specifications and programs to generate SDTMs and analysis datasets using Agios or CDISC standards or study-specific/submission-specific requirements, review of CRFs and creation of SDTM-annotated CRFs, review of statistical analyses plans, analyses data sets, and outputs, hands-on statistical programming activities, and review of deliverables from CROs. The successful candidate must have working knowledge of CDISC requirements and Pinnacle 21.
What you will do:
- Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex 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.
- Create SDTM-annotated CRFs
- Accountable for study-level or submission-level statistical programming deliverables on assigned projects, including timeliness and quality of deliverables.
- Review statistical analyses plans and case report forms.
- Develop or validate specifications and programs to generate tables, listings, and figures based on Agios standards or study-specific/submission-specific requirements.
- 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 or indication-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 12+ years biopharmaceutical industry experience
- 6+ 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 SDTMs, analysis datasets, tables, listings, and figures.
- Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
- Hands-on experience on SDTM mapping from various data sources
- Experience supporting electronic submissions in the eCTD format.
- Excellent oral and written communication skills
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
What we will give you:
- Deliberate Development. Your professional growth as one of our top priorities.
- Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
- 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 performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
- Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
- 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.
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.