What are the responsibilities and job description for the Manager, Clinical Data Analytics position at Agios Pharmaceuticals?
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 Manager, Clinical Data Analytics to join our growing CDOC 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 Manager, Clinical Data Analytics will be responsible for serving as a subject matter expert on clinical data warehouse development, data reporting mapping. Contributes to the development of data visualization, reporting and analytics for clinical studies. This position manages, contributes, and supports the integration of different clinical systems data into clinical data warehouse/ data review / analytics platform to enhance efficiencies in collaboration with key stakeholders for cross-functional data review. Serves as key contact for data reporting, and standard data review platform development and implementation to meet operational excellence and enable risk-based data quality monitoring of clinical trial. Manager, Clinical Data Analytics, works closely with other members of the Clinical Systems & Data Solutions, Data Management, Clinical Operations, Biometrics, Clinical Science and Safety team on various clinical projects with business stakeholders and CRO partners. This position works closely with other members of the Biometrics, Clinical Science and Data Management team on various clinical projects with business stakeholders and CRO partners.
What you will do:
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.
What we will give you:
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 Manager, Clinical Data Analytics to join our growing CDOC 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 Manager, Clinical Data Analytics will be responsible for serving as a subject matter expert on clinical data warehouse development, data reporting mapping. Contributes to the development of data visualization, reporting and analytics for clinical studies. This position manages, contributes, and supports the integration of different clinical systems data into clinical data warehouse/ data review / analytics platform to enhance efficiencies in collaboration with key stakeholders for cross-functional data review. Serves as key contact for data reporting, and standard data review platform development and implementation to meet operational excellence and enable risk-based data quality monitoring of clinical trial. Manager, Clinical Data Analytics, works closely with other members of the Clinical Systems & Data Solutions, Data Management, Clinical Operations, Biometrics, Clinical Science and Safety team on various clinical projects with business stakeholders and CRO partners. This position works closely with other members of the Biometrics, Clinical Science and Data Management team on various clinical projects with business stakeholders and CRO partners.
What you will do:
- Design, develop and maintain data mappings, data rules, and data transformations to populate clinical data warehouse with source data to provide one data review reporting/analytics solution for the cross functional stakeholders.
- Serves as a subject matter expert and provides expertise for study database development, reporting data mapping programming; provides expertise on problem-solving with clinical data, functionality and capabilities.
- Provides input into assessment of new technologies, collaborates with cross-functional teams, IT and QA for implementation, validation and rollout as necessary
- Partners with IT and QA to test and implement system upgrades for elluminate system.
- Supports development of departmental SOPs and processes
- Provides application administration and technical support for tools such as elluminate, spotfire, SQL Server or other reporting tools.
- Performs programming, testing, mapping, data feeds and documentation in accordance with programming standards and validation procedures using reporting tools such as elluminate Data Central, elluminate Analytics, Tibco Spotfire, SQL server or other reporting tools to support the study teams.
- Program and generate data review tools such as patient profiles and targeted data listings in support of data review.
- Works with clinical trial project teams and management to adhere to quality standards and project timelines.
- Must be able to perform under tight timeframes and execute problem solving skills.
- BA/BS in a relevant field and 5 years industry experience (Pharmaceutical, Biotech, CRO) performing reporting/analytics programming, data warehouse management experience
- Excellent problem solving, negotiation, resource allocation and organizational skills. Demonstrated experience collaborating with various business functions
- Demonstrated technical expertise with clinical databases, data warehousing, data analytics platforms and/or data visualization tools.
- Proficient knowledge of data reporting and programming efficiency in SQL, PL/SQL and working with relational databases like SQL Server, MySQL, Oracle, etc.
- Demonstrated strong aptitude for data analytics, mathematical and statistical concepts
- Experience with and understanding of clinical trials and clinical data.
- Demonstrated experience and knowledge in the administration and development of data analytics platforms and/or data visualization tools
- Demonstrated experience working with IT, Quality and cross-functional counterparts in evaluating and implementing clinical data warehouse/ data analytics systems, constructing technical business requirements, specifications and supporting validation documentation
- Knowledge of regulatory guidelines, including GCP/ICH, FDA/EMA/CHMP, 21 CFR Part 11, validation requirements
- Experience and knowledge in the application of data standards, including CDISC standards
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.
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.
