Principal Statistical Programmer I

An exciting opportunity has arisen in our Clinical Development Division for a Senior Statistical Programmer who will be a member of the Biostatistics team and play an important role in performing specific statistical programming tasks required for clinical trial analysis and reporting.

Reporting to the Associate Director, Clinical Standards and Programming, this position will work closely with other members of the BDPM on various clinical projects.

The jobholder may function as Lead Statistical Programmer on a specific project and will have support responsibilities with potential for matrix management, participation in global teams, interacting with regulatory agencies in multiple countries.

Your key accountabilities will include, but not limited to:

• Direct the work of statistical programming services provided by vendors to achieve quality, timely, and cost-effective study deliverables.
• Participate in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines
• Perform statistical programming for clinical trial data analysis and reports
• Assist to establish and implement programming standards and comply with regulatory requirements among project team members and across all studies
• Review deliverables before transfer to either internal or external sources

To be successful in this role, the jobholder will have:

Education & Qualifications

• MS/PhD in Statistics (or equivalent), plus undergraduate degree in a quantitative field.

Skills & Experience

• At least 4 years of experiences in Clinical Development in a Pharmaceutical or Biotechnology setting
• Experience in statistical programming projects in the pharmaceutical industry demonstrated by the ability to independently act as a statistical programmer for all phases of clinical trials.
• Experiences in SAS language procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH;
• Exhibit mastery of project management tasks and skills as related to statistical programming including teamwork, planning, organization, delegation, coordination, metrics, and oversight of contractors;
• Solid knowledge of CDISC standard and its implementation 
• Demonstrate strong knowledge in medical terminology and clinical trial methodologies.
• Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong drug development knowledge
• Fluent in English (oral and written). 

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As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.