Job Description:

Statistical Programmer Analyst III

SUMMARY DESCRIPTION

The Statistical Programmer Analyst III applies intermediate to advanced programming techniques and assists in the planning, design, development, verification, implementation and maintenance of software used for monitoring, analyzing and reporting of clinical trials data in support of regulatory submissions and publications.

RESPONSIBILITIES

• Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
• Collaborates with project lead Statistical Programmer Analyst to develop the statistical deliverables planning and design work
• Completes study statistical programming deliverables to meet project timelines
• Completes program development and documentation of data sets, tables, listings and graphs
• Conducts program verification, identifies bugs and resolves technical problems
• Monitors every aspect of statistical programming deliverables quality through data collection to database lock to distribution of final deliverables
• Assists in the preparation and distribution of reports to the project team members
• Builds effective working relationships with cross functional groups within Biometrics and the study team
• Develops standard reporting tools for the statistical programming group
• Participates in developing Biometrics SOPs
• Participates in overseeing CRO activities and reviewing CRO deliverables as necessary


EDUCATION

Minimum educational experience is a BS in computer science, mathematics, statistics, or related analytic field.
Preferred educational experience is a MS in Statistics/Biostatistics/Biometrics or related field.

EXPERIENCE

Clinical Trials
• A minimum of 4 years SAS programming experience in pharmaceutical and/or biotech company
• Knowledgeable of clinical operations and data management roles
• Knowledgeable of data collection practices and data flow
• Commanding understanding of the Biometrics role in a clinical trials setting

Statistical Programming
• Intermediate to advanced knowledge of Base SAS including macro language and proc report
• Intermediate knowledge of SAS/GRAPH
• Intermediate knowledge of SAS/STAT or other statistical software
• University level statistics course(s) or equivalent experience in statistics
• Ability to interpret tabular and graphical clinical data presentations

Computer Systems
• Must possess understanding of computers at system level with proficiency in UNIX preferred
• Basic understanding of scripting
• Basic understanding of Internet architecture and web development desirable
• Working knowledge of Oracle Clinical or other clinical data management software is desirable

Desktop
• Intermediate Word, Excel and PowerPoint
• Basic Ms Project desirable

Regulatory
• Intermediate knowledge of regulatory guidelines and the software development life cycle
• Electronic NDA and/or BLA submissions via eCTD preferred
• Experience responding to FDA/regulatory requests preferred

Communication
• Capable of well organized, concise and clear written and verbal communication
• Capable of comprehending written specifications and translating them into well documented and clearly structured programs
• Effective at explaining technical concepts to a varied audience in both an individual and group setting
• Effective presentation skills

Project Management
• Capable of leading and independently managing projects
• Capable of working on multiple tasks and shifting priorities
• Motivated and shows initiative
• Detail oriented