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ClinChoice
last mo.

Director Statistical Programming(m/w/x)

Mainz
Full-timeRemoteSenior
AI/ML

Description

In this role, you will lead a team to enhance statistical programming efficiency, ensuring high-quality data analysis and compliance with regulatory standards while collaborating with various departments to meet project timelines.

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Requirements

  • •Bachelor’s degree in Statistics, Mathematics, Computer Science, or related discipline
  • •15+ years experience in pharmaceutical industry, CRO, or clinical research setting with focus on oncology
  • •Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
  • •Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
  • •Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
  • •Solid understanding of the drug development process from early to late-stage development and submission
  • •Expertise in the requirements and technology to support electronic submissions
  • •Strong interpersonal skills and exceptional written and oral communication skills
  • •Strong analytical, project management, and problem-solving skills
  • •Ability to work in a fast-paced and dynamic environment

Education

Bachelor's degree
OR
Master's degree

Work Experience

15 years

Tasks

  • •Implement strategies to maximize efficiency in statistical analysis and reporting
  • •Oversee a team of FSP programmers and vendor CROs for timely delivery of analysis datasets
  • •Align programming strategies with regulatory requirements and compound objectives
  • •Drive the creation and validation of SAS/R programs for clinical data analysis
  • •Ensure adherence to SOPs and regulatory standards
  • •Collaborate with Biostatistics and Clinical Development on study designs and analysis plans
  • •Represent programming in clinical study team meetings and protocol reviews
  • •Lead programming contributions to global regulatory submissions
  • •Manage production of submission-ready datasets and documentation
  • •Champion the adoption of advanced analytics and automation tools
  • •Develop standardized processes and mentor teams on industry trends
  • •Establish efficient processes and innovative solutions for statistical reporting
  • •Participate in continuous improvement activities for clinical operations

Tools & Technologies

SAS

Languages

English – Business Fluent

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