Company: BioPier, LLC. (a Veramed Company)
Position: Senior/Principal Programmer
Type: Full-time
Brief Description: Join the talented team at BioPier, LLC., a Veramed company, as we seek skilled and motivated programmers eager to advance their careers in the dynamic field of drug development and clinical data science. With a strong emphasis on professional growth and development, this full-time position offers a supportive environment with comprehensive training opportunities. You'll work on impactful projects in biostatistics and clinical trials while making significant contributions to our ongoing efforts in the industry.
This is a fantastic opportunity for a Senior or Principal level Statistical Programmer to become a vital member of our organization in the United States. We provide flexible working arrangements, whether at home or in the office, along with a competitive benefits package.
Position Responsibilities: Statistical Programming: - Conduct clinical study reports (CSRs) for Phase I-IV to assess safety and efficacy.
- Engage in data science projects and standardization initiatives, including CDASH, CDISC SDTM, and ADaM.
- Compile integrated summaries of safety and efficacy for drug approvals.
- Prepare regulatory patient safety reports such as PBRER, DSUR, and PSUR.
- Support Independent Data Monitoring Committees with patient profiles and narratives.
At Veramed, we pride ourselves on delivering high-quality statistics and programming consultancy, paired with an industry-leading working environment that fosters employee growth and development.
Key Responsibilities: - Review clinical trial documents, including protocols, SAPs, CRFs, and CSRs.
- Author, review, and approve study TFL shells and dataset specifications.
- Develop, validate, and document SAS programs for datasets, TFLs, and macros while adhering to best practices.
- Identify data issues and outliers, ensuring thorough reviews.
- Complete and approve CDISC validation tool reports and manage data standards issues proactively.
- Maintain proficiency in SAS and stay updated on industry developments.
- Ensure that study master file documents are kept audit-ready.
General: - Effectively lead internal and client study meetings.
- Present study updates during meetings with clients.
- Share technical and scientific knowledge with team members and colleagues.
- Ensure compliance with internal and client policies and processes.
- Foster collaborative relationships with internal and client teams.
- Contribute to process improvement initiatives.
- Provide internal technical training when appropriate.
Minimum Qualification Requirements: - BSc, MSc, or PhD in a numerical discipline or equivalent industry experience.
- At least 4 years of relevant industry experience.
Additional Requirements: - Understanding of the clinical drug development process, relevant disease areas, endpoints, and study designs.
What to Expect: - A warm, welcoming work environment that fosters both personal and professional growth.
- A supportive management team that promotes open communication and provides tools for career advancement.
- Experience a unique CRO culture focused on effective project and staff management.
- Take ownership of your role while developing your skills and experience.