Statistical Programming Analyst

We are looking for Statistical Programming Analyst for our client in Irvine, CA

Job Title: Statistical Programming Analyst

Job Location: Irvine, CA

Job Type: Contract

“W2 candidates are encouraged to apply. We are unable to sponsor H1b or work with third-party candidates at this time.”

Job Description:

• Plan the execution of programs in statistical programming languages (SAS, R, or Python) within the project.

Responsibilities:

• Develop or modify analysis datasets for inclusion in clinical reports or presentations, Create programs for summary output (tables, listings, or graphs) that meet regulatory and company standards to permit efficient programming, reporting, and review, utilizing statistical programming languages (e.g SAS).
• Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review.
• Perform analysis in response to data requests in collaboration with a designated statistician.
• Other duties assigned by Leadership.

Skills:

• Strong SAS and/or R programming skills.
• Good computer skills in interfacing Microsoft Office Suite with SAS.
• Good written and verbal communication skills and interpersonal relationship skills.
• Solid understanding and knowledge relevant to statistical programming.
• Solid understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting.
• Good problem-solving, organizational, analytical, and critical thinking skills.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment, including the ability to work with vendors and project stakeholders.
• Ability to build productive internal/external working relationships.

Education and Experience:

• This job requires a Bachelor's or Master's Degree in Statistics, Mathematics, Computer Science, or related field.
• Previous statistical programming (e.g. SAS, R, or Python) in clinical trials within a pharmaceutical or medical device industry is preferred.