1 Lead Statistical Programming Analyst Job in Lakewood, NJ
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Lead Statistical Programming Analyst
$94k-120k (estimate)
Contractor
1 Week Ago
Connect Life Science is Hiring a Lead Statistical Programming Analyst Near Lakewood, NJ
Seeking an Experienced Statistical Programming Analyst Consultant
Key Responsibilities
Employment Type: Contractor
Key Responsibilities
- Annotation of Case Report Form (CRF) in compliance with FDA/CDISC or sponsor guidelines
- Development of SDTM specifications and creation of SDTM datasets using SAS
- Creation of ADaM specifications and generation of ADaM datasets using SAS based on Statistical Analysis Plan
- Production of Tables, Listings, Graphs, and Patient Profiles to support Clinical Study Reports, Posters, and Manuscripts
- Preparation of ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
- Compilation of electronic submission packages for FDA, such as define.xml or define.pdf, following FDA guidelines
- Analysis of information and innovative problem-solving in programming and data analysis
- Collaboration with statisticians for statistical input and analysis interpretation
- Adherence to regulatory agency requirements in daily tasks
- Leadership of programming team and contribution to departmental initiatives
- Provision of guidance, mentoring, and training for team members and assisting cross-functional teams in issue resolution
- Review of project deliverables to ensure quality and consistency
- Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related fields, with a minimum of 3 years of clinical/statistical programming experience
- Proficiency in high-level computing languages including SAS, C/C , Java, R, Python, MATLAB, and SQL. Database programming experience is advantageous
- Ability to decode programming logic, assemble programming code based on provided logic, and effectively communicate with team members
- Knowledge and application of concepts in Artificial Intelligence and Machine Learning
- Understanding of Good Clinical Practices, Clinical research, Clinical trial processes, and related regulatory requirements
- Familiarity with the clinical drug development process
- Strong communication and coordination skills, capable of interacting with global teams
- Detail-oriented, adaptable to change, and proficient in Microsoft Office Suite
Employment Type: Contractor
Job Summary
JOB TYPE
Contractor
SALARY
$94k-120k (estimate)
POST DATE
06/20/2024
EXPIRATION DATE
07/18/2024
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