Full-Time Principal Statistical Programmer

Principal Statistical Programmer

Servier Bio-Innovation LLC, Boston, Massachusetts (remote)

• Serving as technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed.
• Ensuring high quality, traceability, reproducibility, and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.
• Collaborating with statisticians, local and Contract Research Organization (CRO) programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.
• Ensuring the statistical programming systems, processes, and deliverables align with the relevant regulatory requirements, such as clinical study reporting; electronic records handling; and electronic submission of clinical data to agencies.

Requirements:

• Master's or Bachelor's in Statistics, Pharmacology, Health Care, or related field.
• Six/Eight years of experience as a statistical programmer conducting statistical analysis to support clinical development in the pharmaceutical industry.
• Experience with: (i) Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) guidelines; (ii) Using SAS and R; and (iii) Managing projects that follow Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.

Position eligible for telecommuting from any location within the United States.

Pay Range: $106,600 to $175,785.22 per year.

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