Address
Form of workESSENTIAL JOB FUNCTIONS:
As part of a growing dynamic Biopharmaceutical company, this dual role is responsible for both: in-house clinical data programming responsibilities in support of the study teams; and providing functional leadership to select data processing SaaS providers. This role will work closely with Clinical Data Scientists and other study team members, to develop outputs to support clinical study team data review/display needs, and dashboard creation. In SaaS vendor functional oversight, this role will maximize Kura value through: facilitating utilization, translating business needs into solutions, adoption of custom or new system functionality, escalation/governance support, and partnering with business system owners in support of system use. Requires experience in working in a regulated environment, working closely with users to translate data review/presentation business requirements into to fit for purpose data displays.
- Independent creation of data outputs in support of clinical team data review and cleaning activities.
- With minimal supervision, perform stakeholder management, negotiation of timelines and scope of deliverables.
- Development of business processes and procedures to ensure quality and integrity of internal clinical programming activities.
- Creation and management of clinical programming related standards and tools.
- Serve as functional owner for one or more clinical systems that support data storage, transfer, programing, review, or presentation. Developing and maintaining supporting systems & business processes.
- Accountable for contract and budget management of supported clinical systems.
- Lead study team adoption/implementation/maintenance of Kura's data visualization platform
- Develop business processes and tools to promote consistency in data review across studies and platforms.
- Creation of KPI and dashboard programming to provide transparency into clinical study data health.
- Development of metrics to evaluate SaaS data review/analytic tools to demonstrate business value.
- Facilitating translation of study team member business requirements into effectual data presentations per agreed to timelines.
- Define & manage Clinical Data Science's technical processes for utilization of Egnyte GxP file sharing utility
- Complete other duties as assigned by the
JOB SPECIFICATIONS:
- A./B.S. degree in Mathematics, Computer Science or related scientific field.
- Minimum 3 to 5+ years in relevant work experience in the pharmaceutical/biopharma industry; with 2+ years' experience in clinical programming with SAS.
- Experience in SaaS vendor management.
- Strong SAS programming skills, able to work independently.
- Experience in oncology preferred.
- Effective project management skills
- Strong vendor management skills
- Experience with SaaS clinical data review platforms (e.g. Saama Platform, Eluminate) strongly desirable
- Strong knowledge of SDTM data standards
- Extensive experience working with EDC and 3rd party data sources (Rave, InForm, laboratories, NGS, PK/PD, etc.).
- Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.
- Excellent planning, organization, and time management skills.
- Demonstrated ability to successfully prioritize and deliver parallel project responsibilities.
- Excellent interpersonal skills in addition to verbal and written
- Ability to tailor communications to recipient's level of subject matter understanding.
- Flexibility to travel up to approximately 5% of
The base range for a Sr/Principal Clinical Programmer & Systems Analyst is $146,000 - $175,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
