Alkermes plc (Nasdaq: ALKS) is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and immuno-oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Senior Clinical Programmer
The Senior Clinical Programmer is responsible for clinical programming activities to support data management, data cleaning, data review and surveillance reporting activities for global projects, as well as management of external data specifications, reconciliation programming and effective oversight of external data vendors in partnership with the Data Management Lead.
- Creates standard and/or custom programs/reports using data analytics tools such as SAS, Tableau, or other data visualization tools to support data oversight and review by data managers or other data reviewers.
- Collaborates with Clinical Operations, Clinical Science, Data Management, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review.
- Assists in the management of electronic data from external data sources/vendors in partnership with the Data Management Lead. Liaises with vendors as needed to facilitate electronic data transfers and/or data specification requirements.
- Assists in review and approval of required study documentation, including design specifications, user requirements, data transfer specifications and data standards.
- Generates safety surveillance and/or safety quality data review outputs and patient profiles for Drug Safety and Clinical Sciences' clinical data review
- Provides leadership, training, guidance, and support to other department members on data review tools such as SAS.
- Collaborates with clients, peers, programmers, project teams, and/or requestors to clarify and finalize data specifications; uses expanded technical skills to meet evolving project needs.
- Supports the development, delivery and maintenance of clinical data review standards, tools and systems, across various data sources (e.g., clinical data, safety and operational data).
- Supports initiatives for Data Management, Clinical Programming, Clinical Data Science and/or Safety/Clinical Data Review bridging activities, meetings, discussions.
- Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
- Science and/or Computer Systems/IT background; Bachelor's or healthcare degree
- Minimum 6-8 years' experience in a pharmaceutical/biotech setting
- Advanced technical expertise in databases, EDC platforms, ETL, data imports/integrations
- Advanced programming and analytical skills using BASE/SAS, SAS/STAT, SAS MACROS
- Data Visualization tools (like Tableau, Spotfire) and Python programming language experience a plus
- Ability to work independently to create standard datasets, program edit checks and produce quality data review outputs
- Demonstrated understanding of CDISC requirements and implementation guidelines, able to create and validate CDISC standard datasets
- Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
- Good written and oral presentation skills and ability to communicate effectively to other programmers and non-technical colleagues
- Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
- Windows applications: Word, Excel, PowerPoint, etc.
Travel domestic and international - up to 20%
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.