PRINCIPAL PROGRAMMER

Key Responsibilities:

• Hands on programming role, supporting deliverables in the study / project / portfolio / standards team, of medium or high complex statistical programming deliverables.

• Strong SAS data manipulation, analysis and reporting skills- with strong output programming experience.

• Strong proficiency implementing the latest CDISC SDTM / ADaM standards.

• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.

• Development and execution of statistical analysis and reporting deliverables (e.g safety and efficacy analysis datasets, tables, listings, figures).

• Expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.

• Provide technical guidance to other statistical programmers, and ensure training and development of team members.

• Lead and manage the programming activities for clinical trials, including development of programming plans, specifications, and programming datasets.

Qualification;

• Bachelor or Master (preferred) Degree in Statistics, Mathematics, Bio informatics and Computer Science.

• Minimum 8 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.

• In-depth knowledge of clinical trial design, statistical analysis, and regulatory guidelines.