Senior Statistical Programming Lead

Bristol Myers Squibb; Brisbane; Presencial; AUD 140.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible Time Off

11 paid company holidays

Global Shutdown

Descripción de la vacante

Bristol Myers Squibb in Brisbane is seeking a Senior Manager of Statistical Programming to lead programming teams and support development, regulatory submission and market acceptance of products. You will design and implement technical solutions for analyzing and reporting clinical data.

This role requires a Bachelor’s in statistics or related field, 6+ years in industry, SAS proficiency, CDISC standards, and experience with e-submission components.

Formación

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 6 years programming experience in industry including support of significant regulatory filings.
• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
• Broad expertise in statistical programming and in developing computing strategies.
• In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.

Responsabilidades

• Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices.
• Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards.
• Leads / Supports the electronic submission preparation and review.
• Develops unambiguous and robust programming specifications (e.g. ADaM specifications).
• Reviews key planning documents to align with project objectives and ensures clarity and completeness of programming assumptions and requirements.

Conocimientos

SAS programming

Statistical programming leadership

Regulatory submission expertise

CDISC standards

Team leadership

Educación

Bachelor’s degree in statistics/biostatistics/mathematics/computer science/life sciences

Herramientas

SAS

MS Office

XML

Pinnacle 21

Descripción del empleo

Bristol Myers Squibb in Brisbane is seeking a Senior Manager of Statistical Programming to lead programming teams and support development, regulatory submission and market acceptance of products. You will design and implement technical solutions for analyzing and reporting clinical data.

This role requires a Bachelor’s in statistics or related field, 6+ years in industry, SAS proficiency, CDISC standards, and experience with e-submission components.