Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, elluminate ® Data Programming. This role will drive the programming and processes in elluminate® to support cross functional data review.
Job Duties and Responsibilities
- Assist in development and delivery of a clinical data strategy that allows the organization to be resilient and responsive to changes in the industry such as evolution in data collection methods, novel techniques for working with data, and changing regulatory requirements.
- Produce validated tables, data listings, and custom reports presenting clinical data summaries for inclusion in reports and data review activities managed by the data management department.
- Explore new programming technology; test, document, and integrate software tools into programming procedures.
- Utilize SAS/SQL programming skills to perform all programming required for internal clinical trial analysis and reporting.
- Collaborate with Data Management to test the applications functionality.
- Provide diagnostic support and fix defects as needed.
- Provide programming solutions and support using the elluminate® Data Intelligence Hub platform. Configuration, migration, and support of the elluminate® platform
- Align cross functional team clinical data review objectives to functionality in elluminate® and deliver gap analysis where applicable
- Participate in development of new processes, best practices, and recommend improvements to all procedures to ensure optimal level of cross functional team satisfaction
- Configure elluminate® software to meet the cross functional team requirements
- Participate in elluminate® implementations by providing business process and product best practices consulting services to support the technical and project management team members
- Provide application administration and technical support as the subject matter expert on core business packages related to elluminate.
- Perform elluminate® programming, testing, mapping, data feeds and documentation in accordance with programming standards.
- Assist in developing and implementing data mappings to import into elluminate.
- Program and generate data review tools, such as patient profiles and data listings, to support data review in Data Central and Clinical Data Analytics.
- Works with clinical trial project teams and management to adhere to quality standards and project timelines.
Key Core Competencies
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing, dynamic company.
- Ability to develop and deliver training materials to achieve team understanding of projects and enable effective delivery.
- Ability to apply extensive programming knowledge and skills
- Ability to implement data validation and data review plans
- Demonstrated proficiency in using systems and technology to achieve work objectives.
- Able to manage competing priorities and encompass company best values.
- Expertise in clinical program indications, end points, dataflow, data integrity, standards, and data quality
- Working Knowledge of ICH, Good Clinical Practice and FDA regulations.
- Extensive knowledge of Base SAS, SAS/STAT, SAS macros, and EDC.
- Extensive knowledge of SQL data analytics.
- Effective time management and organization skills.
- Demonstrated proficiency in managing the lifecycle of clinical data projects.
- Experience with drug development in oncology required.
- Strong leadership skills and ability to work within cross-functional teams.
- Expertise in clinical program indications, end points, dataflow, data integrity, standards, data quality and inspection readiness.
- Excellent understanding of relational database concepts, data modelling, and design
Education and Experience
- Bachelor’s degree in computer science or related field, or equivalent combination of education and relevant work experience
- Minimum of 6 years of industry experience
- 3+ years of working experience in SAS programming, digital transformation, technology delivery and client servicing
- 1+ years’ experience in elluminate ® mapping and data transformation.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
The base salary range for this role is $145,600 $182,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW
EEO is the Law Poster Supplement
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