Statistical Programmer I

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.
• Affords assistance in 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)
• 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.