Principal Statistical Programmer

Company Description

MEDTEK AI is a data science-driven company focused on supporting faster drug development and healthcare solutions. Our team consists of senior statisticians, data scientists, statistical modeling and programming experts, data visualization specialists, cloud data engineers, data lake strategists, and regulatory submission and drug safety consultants. We provide comprehensive support to pharmaceutical and biotech companies across North America, Japan, and the EU.

Role Description

• 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

Qualificaitons:

• 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.