Responsibilities:
Provides SAS programming support to all clinical studies.
Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
Provide 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 SAS programming instructions and CDISC/ADaM specifications.
Performs statistical analysis and simulations using SAS 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 related 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 impact 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 methods in similar studies within a program.
Requirements:
Bachelor's degree or master's degree or higher in statistics, biostatistics, or other closely related 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 variety 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 related to clinical trials operations requirements.
In depth knowledge of CDISC and ADaM data set structures and requirements.
Proficiency with SAS programming skills to including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL) Knowledge of all 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 well in a team environment as a contributor.
...sets. About This Role At Automated Logic, a Carrier Company, we provide a work home for those ready to lead in the field. As a Field Engineer, you deliver durable solutions by applying sound technicaljudgmentto complex project challenges. We are looking for...
Job Description We are seeking a highly credentialed junior Trusts & Estates Associate (Class of 2024 or 2025) to join a leading Am Law 100 law firm in New York City. \n \n The position is within a sophisticated Private Client practice advising high-net-worth and...
...Prince of Peace Catholic Church is seeking applicants for the position of Director of Music and Choirmaster to continue our parish's renowned sacred music program, comprising five choirs, two organs, and three weekly sung Masses. The full-time Director of Music oversees...
...mothers, female executives, and scientists. The Opportunity: Our Core Lab business unit currently has an opportunity for a Clinical Research Associate. This role is based remote in the United States near a major airport or in an Abbott Office approved. Our...
Acceleration Academies is seeking a Student Advocate to support graduation-focused programs across our academy locations. Youll build meaningful relationships, assist with enrollment and orientation, and help students overcome barriers to attendance and progress.This...