Washington, Washington DC, United States Hybrid / WFH Options
Leidos
research including seven (7) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISCdatastandards preferred. Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG More ❯
in pharmaceutical product development and Total Life Cycle Cost (TLCC) management. Ability to obtain and maintain NACI Background Check. Desired Qualifications: Extensive knowledge of FDA/ICH guidelines and CDISCdatastandards preferred. About the Company: Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over More ❯
Washington, Washington DC, United States Hybrid / WFH Options
Leidos
research including five (5) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISCdatastandards preferred. Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG More ❯
research including five (5) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISCdatastandards preferred. • Advanced degree in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or master's (with commensurate experience) of science in a physical science field More ❯
pharmaceutical product development and Total Life Cycle Cost (TLCC) management. Ability to obtain and maintain a NACI Background Check. Desired Qualifications: Extensive knowledge of FDA/ICH guidelines and CDISCdatastandards preferred. About the Company: Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over More ❯
programs to generate datasets, tables, listings, and figures (TLFs) for clinical and observational studies. Support programming deliverables across Phase IV, Medical Affairs, RWE, and HEOR studies. Ensure adherence to CDISCstandards (SDTM and ADaM) for data structure and analysis. Collaborate with biostatisticians to implement statistical analysis plans (SAPs) and provide programming input during study design. Perform quality control (QC) checks … IV, Medical Affairs, Real World Evidence (RWE), or Health Economics and Outcomes Research (HEOR) studies. Hands-on experience in SAS programming; experience in R is an advantage. Experience with CDISCstandards, including SDTM and ADaM datasets. Experience with Real World Data (RWD) and RWE methodologies, including propensity score analysis and causal inference. Familiarity with advanced statistical models, such as mixed More ❯
clinical projects, including complex projects. Support the identification of scope changes and potential risks to contractual delivery. Act as support statistical programmer on clinical projects. Specify, program, and validate CDISC SDTM and ADaM datasets. Specify, program, and validate statistical analysis results, including datasets, tables, listings, and figures. Produce and review CDISC documentation. Create and validate randomization lists. Ensure compliance with More ❯