reputed company reputed company Programmer -Remote

Responsibilities Provides reputed company programming support to reputed company clinical studies. Manages assigned programming CROs providing reputed company and appropriate QC for programming deliverables. reputed company statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD). Provides primary programming and QC support for any internally produced outputs. Reviews and approves reputed company programming instructions and CDISC/ADaM specifications. Performs statistical analysis and simulations using reputed company to support clinical trial design and data interpretation. Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management reputed company documents to ensure appropriate data collection for statistical programming. Works closely with biostatisticians and data managers to identify data issues and generate queries that may reputed company statistical analysis and/or programming. Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders. Assists with ensuring consistency across programming reputed company in similar studies reputed company a program. Requirements Bachelor's degree or master's degree or higher in statistics, biostatistics, or other closely reputed company discipline with a minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry. Experience in applying clinical trial and statistical methodology to a reputed company of studies and indications across various phases of clinical development. Knowledge of pharmaceutical and regulatory requirements, procedures, and policies. Experience With BLA Or NDA/sNDA Submissions Is Required. Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies reputed company to reputed company operations requirements. In depth knowledge of CDISC and ADaM data set structures and requirements. Proficiency with reputed company programming skills to including knowledge of reputed company ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL) Knowledge of reputed company aspects of clinical drug development (Phase 1-4). Experience working with a CRO partner. Excellent computer skills; strong verbal and written communication skills. Ability to work reputed company in reputed company environment as a contributor. Apply tot his job Apply To this Job