Senior Manager/Associate Director, Business Systems Analyst – Remote Position Available In Montgomery, Pennsylvania

Job Description:

Who we are: Agios is a biopharmaceutical company that is fueledby connections. We thrive in a supportive, fun, and flexibleenvironment full of people empowered to bring their whole selves towork. We care deeply about our work, each other, and the patientswho count on us. Our teams cultivate strong bonds with patientcommunities, healthcare professionals, partners and colleagues,which helps us discover, develop and deliver therapies forgenetically defined diseases – and make a bigger difference intheir lives. In the U.S., Agios markets a first-in-class pyruvatekinase (PK) activator for the treatment of hemolytic anemia inadults with PK deficiency. Building on the company’s leadership inthe field of cellular metabolism, Agios is advancing a robustclinical pipeline of investigational medicines with active andplanned programs in alpha- and beta-thalassemia, sickle celldisease, pediatric PK deficiency and MDS-associated anemia.

Theimpact you will make:

Agios Pharmaceuticals is searching for adynamic Clinical R D Business Systems Analyst (BSA) to join ourgrowing IT team. We want someone who cares about this importantwork, and who’s driven to connect to our mission of helping thesepatient communities. The Clinical R D Business Systems Analystwill be responsible for understanding our overall ClinicalDevelopment, Clinical Operations, Regulatory, Medical Safety,Biostatistics strategies, they will also serve as the strategicinterface for the purpose of technology strategy execution betweenthe IT organization and the functions listed above. This is ahands-on role requiring strong internal partnerships with R Dteams to deliver innovative solutions that meet evolving businessneeds. The BSA will analyze and support the design of processes andguide the business in the comparison and selection of right-sizedand intentional business systems. The BSA will have an in-depthunderstanding of how the business leverages current systems anddata today, and how we can develop and enhance solutions thatenable the organization to meet future business needs. Thisresource will need to be flexible and have general BSA skills, toassist on many diverse types of projects. To accomplish this, weare looking for a business systems analyst who can: Perform thetraditional functions expected of a Business Systems Analyst -document requirements, develop flow diagrams, and understandbusiness processes and analyzing and streamlining the businessprocesses. Act as a ‘product manager’ for their domain – goingbeyond simple requirements elicitation and help define solutionsthat anticipate future needs, leverage knowledge of industrytrends, and future proof our investments. Create and execute testscripts and facilitate the UAT process, ensuring stakeholdersunderstand capabilities, test complete solution and supporting datafor user experience, and ensure solutions are easy to navigate andconsume. In collaboration with IT Business Partner, serve as aninterface between the IT organization and the business functionalsSME. Interface with functional solution delivery team to translatecustomer requirements into detailed technical specifications to beused in the solution design and development process.

What you willdo:

Work with the business SME to clearly define user requirementsand translate the requirements into detailed functionalrequirements to be used in the solution design and developmentprocess and communicating delivery status to the business. Assistbusiness SME team to prioritize enhancements using Agilemethodology including backlog grooming and creation of userstories. Orchestrate full cycle delivery of IT applications inpartnership with the solution delivery team and ensure successfulchange management, implementation (planning, execution, anddelivery) and operational support. Create and deliver documentationrequired per established project implementation process for eachphase of SDLC including but not limited to creating Userrequirements doc, system impact assessment, Test plan, Testscripts, traceability matrix, training plan, communications plan,end user guides, RAID logs, status reports, data migration plan,etc. Design and document operational workflows, the development andexecution of the roll out strategies, end-user training andsupport, and end-user documentation. Collaborate with business SME,IT system owners and vendors to plan and execute quarterly releaseand upgrade management and associated business critical regressiontesting. Develop test scenarios and test cases, including executionof unit testing and facilitate UAT. Assess new opportunities for ITsolutions and utilization to further drug development efforts, andinitiate projects and efforts accordingly. Identify opportunitiesfor functional improvements and enhancements to maximize theeffectiveness of available technology. Act as business SME fortechnical development staff in all phases of the development andimplementation process. Troubleshoot critical production issuesthrough discussion with end users, managed service vendor andoperations team. Includes problem triage/recognition, research, andisolation and resolution steps. Working knowledge of projectmanagement methodologies. Manage project deliverables per AgiosSDLC. Collaborate with Program Management Office (PMO) for processand status reporting on key project deliverables and milestones.

Interact and support Clinical R D systems including and notlimited to CTMS, eTMF, EDC, IRT, RIM, Clinical Data Warehouse,Pharmacovigilance / Drug Safety What you bring: BS (ComputerScience/Computer Engineering/Systems Engineering) or a relatedtechnical discipline or equivalent combination of education,technical training or work experience. Strong background inimplementing and supporting GxP systems and computer systemsvalidation process and documentation.6 to 8 years of relatedsuccesses with in-depth knowledge of key Clinical systems such asVeeva Vault, SAS, Medidata and Argus platforms (or theircompetitors). Experience in pharmaceutical/biotechnology and anunderstanding of clinical trials operations and regulationsincluding

FDA, MHRA

Well versed in GAMP 5 and Computer SystemsAssurance Demonstrated ability to analyze complex issues, todevelop relevant and realistic recommendations and plans, and todrive projects to consistently meet deadlines. Good listeningskills with ability to make timely well-informed decisionsEffective communicator (written and oral) across all levels oforganization, including users, developers and line level managementin multiple time zones. Knowledgeable about Software DevelopmentLife Cycle (SDLC) models. Must communicate clearly and effectivelywith both technical and non-technical stakeholders. Skilled inactive listening ensuring mutual understanding and alignment acrossall levels of organization. Ability to solve complex problems withcritical thinking and analysis and make compelling and persuasivepresentations to win approval for recommendations. Ability tolisten and collaborate with clients to generate forward-thinkinginnovative solutions that deliver practical and sustainableresults. Work independently with minimal supervision withdemonstrated experience working in a matrix environment. Strongability to troubleshoot issues independently, prioritizing taskseffectively while managing high quality deliverables. Strong teamplayer that has a customer service approach and is solutionoriented. Experience with vendor management and oversight of dataexchange, migration, and integration Preferred QualificationsBachelor’s Degree with PMP or Master’s degree. Consultingbackground with recent client facing experience. Recent experiencein Life Sciences with flexibility to adapt to the dynamic needs ofa growing pharmaceutical company and to manage change effectively.

Experience with implementing and supporting regulated systems RIM,CTMS, eTMF, Drug Safety in an organization with multiple businessunits/entities. Experience managing complex projects andintegrations across multiple modules in a platform and standalonesystems. Experience with Veeva Vault platform, Oracle Argus,Egnyte, SAS, RStudio, RAVE EDC, Elluminate, Spotfire. Concernedthat you don’t check off every box in the requirements listedabove? Please apply anyway! At Agios, we value each other’sdifferences and recognize that teams thrive when everyone bringstheir unique experiences to the table. We are dedicated to buildingan inclusive, diverse, equitable, and accessible environment whereall employees can bring their whole selves to work. If you’reexcited about this role but your previous experience doesn’t alignperfectly with the job description, we still encourage you toapply. You may be just the right candidate for this role or anotheropening!

Work Location:

Location Agnostic:

Work location for thisrole is based on employees individual preference. This role has theability to be either remote in the US or hybrid in our CambridgeHeadquarters. Hybrid schedules vary but are generally less than 3days per week onsite and hybrid employees are expected to livewithin commutable distance to our Cambridge Headquarters. Remoteemployees work entirely from home except for attending Companysponsored events/ meetings. For employees who choose to workremotely, travel may be required for certain company eventscommensurate to the above job description.

What we will give you:

Deliberate Development. Your professional growth as one of our toppriorities. Flexibility. We’re all about individual needs. Weembrace different perspectives, work styles, health and wellnessapproaches, care of families and productivity. When you’re at yourbest, we’re at our best. Premium benefits package. We invest in thehealth, wellbeing, and security of our people with a premiumbenefits package that is well-rounded and flexible to help meet thevaried personal and professional needs of every member of our team.

Competitive and equitable performance-based compensation. Thisincludes base salary and both short- and long-term incentives thatare connected to our business strategy and vary based on individualand company performance. The current base salary range for thisposition at the Sr. Manager level is expected to be between$127,219 and $190,828 annualized and the current base salary rangefor this position at the Associate Director level is expected to bebetween $149,069 and $223,604 annualized; final salary will bedetermined based on various factors including, but not limited to,years of relevant experience, job knowledge, skills andproficiency, degree/education, and internal comparators.

Psychological safety. We support an environment of fearlessness. Wewant you to share your ideas, speak candidly and take data-informedrisks to help push the boundaries. Commitment to diversity. Westrive to foster a welcoming workplace where everyone can thrive.

We’re continuously looking to improve the inclusivity of ourworkforce. Commitment to community. We’re an active participant inthe communities that surround us – the communities where we live,and the community of people and their loved ones in need of bettertreatment options for conditions that are often overlooked.