New Job?Nejo!

The AI Job Search Engine

BI
BioNTech SE
6mo ago

Director Statistical Programming (Oncology)(m/w/x)

Mainz, München
Full-timeOn-siteManagement
AI/ML

Description

You lead statistical programming efforts, ensuring high-quality data analysis and regulatory compliance while collaborating with various teams to optimize processes and improve efficiency in clinical trials.

Let AI find the perfect jobs for you!

Upload your CV and Nejo AI will find matching job offers for you.

Requirements

  • •Bachelor’s degree in Statistics or related discipline
  • •15+ years experience in pharmaceutical industry
  • •Excellent knowledge of statistical programming in SAS
  • •Solid understanding of FDA and global regulations
  • •Solid understanding of CDISC standards
  • •Solid understanding of drug development process
  • •Expertise in electronic submissions technology
  • •Strong interpersonal and communication skills
  • •Strong analytical and problem-solving skills
  • •Ability to work in a fast-paced environment

Education

Bachelor's degree
OR
Master's degree

Work Experience

15 years

Tasks

  • •Implement strategies to enhance statistical analysis efficiency.
  • •Oversee FSP programmers and vendor CROs for timely delivery.
  • •Align programming with regulatory requirements and objectives.
  • •Drive creation and validation of SAS/R programs for analysis.
  • •Ensure compliance with SOPs and regulatory standards.
  • •Collaborate with teams to shape study designs and analysis plans.
  • •Represent programming in clinical study team meetings.
  • •Lead programming for global regulatory submissions.
  • •Manage production of submission-ready datasets and documentation.
  • •Promote advanced analytics and automation tools for efficiency.
  • •Develop standardized processes and mentor teams on trends.
  • •Establish innovative solutions to enhance statistical reporting.
  • •Participate in continuous improvement for clinical initiatives.

Tools & Technologies

SASCDISC standards

Benefits

Mental Health Support

  • •Commitment to team wellbeing

Competitive Pay

  • •Competitive remuneration packages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
100+ Similar Jobs for you
  • BioNTech SE

    Director Clinical Operations(m/w/x)

    Full-timeOn-siteSenior
    Mainz
  • BioNTech SE

    Director Translational Sciences (Oncology)(m/w/x)

    Full-timeOn-siteSenior
    Mainz
  • BioNTech SE

    Director Global Regulatory Affairs (Oncology)(m/w/x)

    Full-timeOn-siteSenior
    Mainz, München
  • BioNTech SE

    Associate Director Clinical Trials(m/w/x)

    Full-timeOn-siteSenior
    Mainz
  • BioNTech SE

    Director Process Improvement Global Clinical Development Operations(m/w/x)

    Full-timeOn-siteExperienced
    Mainz
100+ View all similar jobs
Apply now