Statistical Analyst (Remote, R or SAS Programmer)

· Effectively design and code for assigned clinical project(s).Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.

· Create and validate tables, figures and listings (TFLs) working closely with cross-functional teams in a timely and high quality fashion, consistently meeting objectives of the study, and regulatory requirements.

· Perform quality control checks/validation of SAS or R code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.

· Create and review aCRF, SDTM and ADaM datasets specifications for datasets programming.

· Provide programming support for adhoc analysis and periodical safety reports.

· Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).

· Provide oversight of statistical programming activities of vendors.

· Participate in development of Statistical Programming deliverables processes and standards, as appropriate.

· Developing applications and tools in support of data visualization, exploratory analysis and reporting, including the use of R Shiny as the reporting layer, and R and/or SAS for any pre-processing/data manipulation.

· MS in Statistics, Math, Computer Science with at least 2 year of programming experience using SAS or R in the pharmaceutical or biotech or CRO industry.

· Experience in providing statistical programming support to early and late phase clinical trials

· Excellent skills in SAS or R programming and statistical reporting.

· In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.

· Familiarity with FDA and ICH regulations and guidelines.

· Excellent problem-solving skills.

· Excellent written and verbal communication skills and organizational and documentation skills.

· Demonstrate positive attitude and the ability to work well with others.

Pulled from the full job description Health insurance Vision insurance Dental insurance, * Dental insurance

• Health insurance
• Vision insurance