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Title:Sr Statistical Programmer Analyst
Salary:Open
Experience:7+
Location:CA - South San Francisco

Description:
As a member of a clinical project team, the Senior Statistical Programmer Analyst applies advanced level programming techniques and leadership to the planning, design, development, implementation, and maintenance of software for the monitoring, reporting, and analysis of clinical trials.

Responsibilities:
  • Designs data warehouse, SCS, SCE databases.
  • Uses creativity and ingenuity to solve complex programming problems (e.g. creates reusable code, develops project/department standard code, designs interconnected programs).
  • Accountable for overall timelines and major project milestones, as well as overall project quality, integrity and productivity.
  • May serve on or lead departmental initiative, specialized projects, and/or working groups.
  •  May serve as Biometrics Team Leaders (BTL).
  • Develops and maintains tools and standard templates.
  • Serves as an expert troubleshooter.

Requirements:
  • Minimum of 7 years of SAS programming with 4 years of clinical trial experience.
  • Knowledge and application of p-values, confidence intervals, linear regression analysis, advanced general linear models, frequencies, survival analysis, non-parametric analysis, randomization software, PROC STATXACT, and proficiency in implementing these ideas in clear, efficient SAS code for the purposes of data analysis and reporting.
  • Intermediate UNIX, Oracle Clinical or equivalent clinical DM system, and relational database theory.
  • Basic knowledge of FDA/ICH guidelines, the software development life cycle, and 21 CFR Part 11 and other FDA regulations.
  • Experience working on FDA submissions.
  • Understands role of all functional areas in clinical trials.
  • Candidate should be capable of clear and timely written and verbal communication with peers, customers, and management.
  • Able to give effective presentations to small groups such as Implementation Teams or Statistical Programming meetings.
  • B.S. in computer science, statistics, biology, or other relevant scientific area.

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