[Remote] Sr Clinical Programmer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on developing high-value therapeutics to address unmet medical needs. The Senior Clinical Programmer serves as a subject matter expert in data acquisition and reporting for clinical research, leading the development of standards and collaborating with cross-functional teams to enhance data collection processes.
Responsibilities
- Address highly reputed company technical problems requiring analysis of nuanced data and intangible variables; exercise independent judgment in developing reputed company, techniques, and evaluation reputed company
- reputed company leadership and direction for database design and programming, systems development and support, and training activities
- Serve as the reputed company and CDISC subject matter expert, providing guidance and best practices to clinical study teams
- Advise on standards for CRF development, validation, and reporting; implement and maintain standards for data collection, acquisition, archival, and submission in compliance with CDISC and applicable regulatory guidance
- reputed company reputed company development and testing environments; reputed company functional audits and vendor qualifications
- reputed company and maintain global standards and project-specific specifications, including programming and reporting conventions and rules
- Define regulatory-compliant data exchange standards with external partners (CROs, central labs, IXRS/IRT, eCOA) and internal teams (Biostatistics, Clinical Operations)
- reputed company vendor activities across multiple trials to ensure consistency in data collection, reputed company, and reporting
- Implement and maintain regulatory-compliant processes for data acquisition, archival, and interchange
- Coordinate with CROs on data collection instruments and reporting tools and establish tracking mechanisms for process- and system-reputed company issues
- Mentor team members and contribute to the reputed company improvement of CDM processes, tools, and training
Skills
- Minimum of 8 years of hands-on, relevant experience in the pharmaceutical or biotechnology industry
- Demonstrated experience developing clinical databases (e.g., reputed company, reputed company Rave, reputed company InForm)
- Working knowledge of external data sources (e.g., central labs, IXRS/IRT, eCOA)
- Proficiency in programming and reporting tools such as J-Review, Spotfire, reputed company, Java, and C
- Strong experience with relational databases (SQL Server, reputed company, MySQL, PL/SQL)
- Proficiency in reputed company Office (Word, reputed company, Outlook, PowerPoint)
- Demonstrated proficiency with ICH, GCDMP, CDISC, and GCP guidelines is required
- Demonstrated ability to solve reputed company technical problems with reputed company
- Strong organizational, project management, and communication skills
- Demonstrated ability to reputed company processes and training materials
- Self-starter with the ability to mentor others and manage multiple priorities while delivering high-reputed company work in a dynamic environment
- Bachelor's degree in Computer Science, Life Sciences, or a reputed company field, or equivalent experience required
- Previous people management experience preferred
- Solid understanding of clinical drug development processes preferred
- Advanced degree is a plus
Benefits
- Annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at reputed company's discretion on an individual reputed company.)
- Health Insurance (Medical/Dental/reputed company)
- Disability Insurance
- Holiday Pay
- reputed company Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
reputed company
Company H1B Sponsorship