SAS Clinical Programmers (New York, NY)

We need several experienced people ( 2 years min for Jr role. # years min for Sr.) re: the following in NYC. Excellent Benefits are provided including 4 weeks paid time off 1st year and 5 weeks 2nd year.

Please respond to: joe [at] g-2-consulting.com

PRIMARY FOCUS

Produce data analysis sets, listings, tables, ad hoc reports and validates programming as required for the effective operation and completion of clinical studies.

SUMMARY

Under limited direction, responsible for the day-to-day development, maintenance and management of multiple clinical study databases and management of queries as requested by both internal and external sources and in compliance with FDA regulations and ICH guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Designs clinical databases for clinical trials, writing database documentation, writing and performing database validation, creating data listings, ad hoc error detection methods and data displays.
• Provides day-to-day oversight of assigned projects.
• Conducts all aspects of data management (e.g., data entry, creation of datasets, edit checks, data cleaning, safety listings and data manipulation) utilizing given software and/or spreadsheet programs as necessary.
• Reviews and contributes to the preparation of Case Report Forms (CRFs).
• Develops query designs, standard tables for the presentation of data, analyses of data and reports as requested.
• Responsible for developing and maintaining SAS standards for report quality tables, listings and figures, and report writing.
• Keeps informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings.
• Conducts regular testing and analysis of the database in order to maintain data integrity; performs quality review of SAS programs generated by other SAS programmers and biostatisticians.
• Generates and updates program codes and data definitions as necessary.
• Works with staff in developing research ideas suitable for publication.
• Provides project guidance and instruction both internally and to study Sponsors regarding database design, implementation and database capabilities.
• Communicates with internal departments and external organizations to facilitate data transfer.
• Furnishes outcomes data to internal departments and external organizations as requested by supervisor.
• Reports and collaborates with information technology consultants as necessary.
• Participates in activities organized to improve operational activities of the department.
• Additional duties as assigned.

QUALIFICATIONS

• SAS Clinical Programmer - B.S. degree from an accredited institution in Computer Sciences or related programming courses or equivalent work experience; advanced degree preferred; a minimum 3 or more year(s) of experience in clinical database programming.
• Senior SAS Clinical Programmer - B.S. degree from an accredited institution in Computer Sciences or related programming courses or equivalent work experience; advanced degree preferred; a minimum 5 or more year(s) of experience in clinical database programming.
• Biomedical experience preferred.
• Knowledge of medical and statistical terminology.
• Knowledge and experience in implementing the GCP/ICH regulations and 21 CFR Part 11 preferred.
• Familiarity and proficiency with computer programs including, but not limited to, Windows, Excel, MS Word and Outlook; working knowledge of MSaccess, Visual Basic, FileMaker Pro and relational databases desirable.
• High level of proficiency in SAS.
• Experience preparing study results for submission using SAS.
• Familiarity with coding dictionaries.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike; ability to verbally communicate effectively with data management, department clinical research and other team members.

URL: www.datashaping.com/jobs17226e.shtml
Please mention datashaping.com when applying. Thank you.