Manager, Clinical Data Analytics

Agios Pharmaceuticals Inc•Cambridge, MA

1d•Remote

About The Position

The Manager, Clinical Data Analytics will manage, contribute, and support 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. 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. Serve as a subject matter expert and provide expertise for study database development, reporting data mapping programming. Provide expertise on problem-solving with clinical data, functionality and capabilities. Provide input into assessment of new technologies, collaborates with cross-functional teams, IT and QA for implementation, validation and rollout as necessary. Partner with IT and QA to test and implement system upgrades for elluminate system. Support development of departmental SOPs and processes. Provide application administration and technical support for tools such as elluminate, spotfire, SQL Server or other reporting tools. Perform programming, testing, mapping, data feeds and documentation in accordance with programming standards and validation procedures using reporting tools such as elluminate Data Central, 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. Work with clinical trial project teams and management to adhere to quality standards and project timelines. Telecommuting available anywhere in the United States.

Requirements

Requires at least Bachelor’s degree or foreign equivalent in Computer Science, Computer Information Technology, or a related field.
Must possess 5 years of progressive postbaccalaureate experience with all of the following: (a) pharmaceutical industry experience performing reporting and analytics programming and data warehouse management; (b) performing programming, testing, mapping, and creating data feeds and documentation using SQL Server; (c) working with clinical databases; (d) creating data visualization using Spotfire (e) working with relational databases SQL Server, MySQL, and Oracle; (f) data reporting and programming in SQL and PL/QL; (g) loading eCFR data from electronic data capturing system and cleaning data; and (h) working with regulatory guidelines including GCP/ICH, FDA/EMA/CHMP, and 21 CFR Part 11.
Experience may be gained concurrently.
Telecommuting available anywhere in the United States.

Responsibilities

Manage, contribute, and support 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.
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.
Serve as a subject matter expert and provide expertise for study database development, reporting data mapping programming.
Provide expertise on problem-solving with clinical data, functionality and capabilities.
Provide input into assessment of new technologies, collaborates with cross-functional teams, IT and QA for implementation, validation and rollout as necessary.
Partner with IT and QA to test and implement system upgrades for elluminate system.
Support development of departmental SOPs and processes.
Provide application administration and technical support for tools such as elluminate, spotfire, SQL Server or other reporting tools.
Perform programming, testing, mapping, data feeds and documentation in accordance with programming standards and validation procedures using reporting tools such as elluminate Data Central, 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.
Work with clinical trial project teams and management to adhere to quality standards and project timelines.

Benefits

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.
For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
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.
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.