Job Description :
Senior Statistical Programmer/Analyst
6 Months
Brisbane, CA

The Senior Statistical Programmer Analyst applies advanced programming techniques and leads 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. This position progressively develops the statistical programming function in alignment with the requirements of the BioMetrics department and organizational goals.
Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
Builds effective working relationships with cross functional groups within BioMetrics, the study team and the company
Negotiates effectively to meet study objectives
Leads development and project management of the statistical deliverables planning and design work
Leads assigned statistical programming team project resources and manages the completion of study statistical programming deliverables to meet project timelines
Monitors contractor programmer project activities and reviews contractor programmer deliverables as necessary
Responsible for every aspect of statistical programming deliverables quality
Conducts program development and verification, identifies bugs and resolves technical problems
Assists in the distribution of reports to the project team members
Investigates trends, identifies techniques and makes recommendations for new methods and technologies used in pharmaceutical and/or biotech industries for reporting and managing clinical data
Participates in the development of standard reporting tools or components and system utilities for the statistical programming group
Contributes to developing BioMetrics SOPs.

Clinical Trials
A minimum of six years SAS programming experience in pharmaceutical and/or biotech company
Thorough knowledge of clinical operations and data management roles
Thorough knowledge of data collection practices and data flow
Commanding understanding of the Biometrics role in a clinical trials setting Statistical Programming
Advanced knowledge of Base SAS including macro language and proc report
Intermediate to advanced knowledge of SAS/GRAPH
Advanced 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
Applied work with CDISC data models including SDTM, ADaM and ODM Computer Systems
Must possess an understanding of computers at system level with proficiency in UNIX Intermediate understanding of scripting desirable
Intermediate understanding of Internet architecture and web development desirable
Intermediate knowledge of Oracle Clinical or other clinical data management software is desirable Desktop
Intermediate Word, Excel and PowerPoint
Intermediate Ms Project desirable Regulatory
In-depth up-to-date knowledge of domestic and international regulatory guidelines and the software development life cycle
Electronic NDA and/or BLA submissions via eCTD
Experience responding to FDA/regulatory requests Project Management
Capable of independently leading and managing projects
Capable of working on multiple tasks and shifting priorities
Motivated and shows initiative
Detail oriented 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

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.