Remote Statistical Programmer Jobs in Hayward, CA

Job Title: 'Statistical Programmer’

Location: Remote

Job Type: Long term contract

Hourly Rate: $80-$90/hr. W2

Expectation:

Sr. level 5+ yrs exp.

Medical affairs, publication support, mainly use clinical studies database, Phase IV/open label studies or observational studies.

Stat background is preferred.

Job Summary (Primary function)

The candidate, RWE Statistics Programming is responsible for statistical programs that process clinical data required for statistical analysis of Phase I — IV clinical trials, observational studies and real world data, playing a key role in support of real-world research projects. They are responsible for ensuring efficiency, timeliness and quality of deliverables of statistical programming analysis.

Essential Functions of the Job (Key responsibilities)

• Conduct statistical programming work of clinical data and real-world data using SAS Software.

• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.

• Generate analysis datasets according to CDISC standard and SAP.

• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct ad hoc analyses.

• Validate programs and associated results produced by other programming colleagues.

• Participate in TLF shell preparation, review and assist statistician for SAP preparation.

• Run CDISC validation programs e.g., Open CDISC reports to ensure ADaM datasets are CDISC compliant.

• Develop standard SAS macros for efficient analyses of clinical data supervised by Programming management.

• Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials.

• Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timeline and deliverable are met.

• Work independently to program for individual studies with minimum supervision.

• Function as a Lead programmer for a compound or a group of studies performing the following functions including maintaining the overall timelines, maintaining programming standards, review standard macros used and review standard datasets used.

• Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.

• Check that the validation summary reports are clean of errors and warnings and show proper documentation of SAS programs.

• Review individual study CDISC validation output.

• Assist in the preparation of statistical reports, presentations, and publications, summarizing findings and providing insights to stakeholders.

• Conduct exploratory and ad hoc data analyses to identify trends, patterns, and associations in real-world data.

• Assess resource needs and to ensure projects are adequately resourced.

• Mentor/Train junior programmers on Incyte systems and standards as they work on studies within their area and assist in new study set-up.

• Provide recommendations and solutions to complex problems.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree (MS degree in statistics or computer sciences is desired).

• Minimum 5 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries.

• Experience with real-world data sources, such as electronic health records, claims data, or patient registries, is preferred.

• Knowledge of applying statistics, programming to epidemiology, real-world data, exploratory and ad hoc analyses.

• Data Management experience including CDISC standard is highly desirable.

• Good SAS programming skills and attention to detail are essential.

• Demonstrate knowledge of regulatory guidelines, including electronic submission standards.

• Strong organizational, time management, communication and project coordination and leadership skills.

• Must be able to work well under timeline pressure.

• Must be able to work on multiple projects and tasks while coordinating with others at the same time.

• Demonstrate experience serving as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems.

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