Statistician Lead

2 days ago

Pune, Maharashtra, India beBeeClinical Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Principal Stat Programmer

 

We are seeking an accomplished Principal Stat Programmer to join our team as a technical subject matter expert (SME) for CDISC and other industry and regulatory standards.

 

  • Serve as a technical SME for CDISC and other industry and regulatory standards, providing guidance and support to internal teams.
  • Contribute to the development of standardized programming tools, macros, and SOPs for efficiency and compliance.
  • Lead multiple complex and/or global clinical trial programming projects, mentoring and guiding statistical programming teams.
  • Ensure compliance of programming deliverables with CDISC standards, regulatory requirements, and internal guidelines.

 

Key Responsibilities:

 

  • Collaborate with biostatistics and programming teams to establish SOPs, guidelines, policies, and procedures.
  • Develop and optimize programming tools and macros for standardization and efficiency.
  • Provide guidance and training to Biostatistics and other departments on CDISC usage.
  • Conduct compliance reviews of project deliverables (SDTM, ADaM, DEFINE.XML, and other regulatory documents).
  • Participate in industry standards organizations and provide updates to the Biometrics department.
  • Transfer deliverables and coordinate with cross-functional teams for project execution.
  • Mentor junior programmers and support their understanding of CDISC standards and clinical trial processes.
  • Perform other work-related duties and minimal travel as required.

 

Qualifications:

 

  • Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and experience).
  • Extensive SAS or equivalent programming experience in clinical trial environments.
  • Knowledge and hands-on experience with CDISC standards (SDTM, ADaM, DEFINE.XML).
  • Regulatory submission experience preferred.
  • Proven experience leading multiple complex or global projects.
  • Experience mentoring others in clinical trial processes and CDISC standards.
  • Excellent written and verbal communication skills; proficiency in English.

 

Skills Required:

 

  • SAS programming and clinical data analysis.
  • CDISC Standards (SDTM, ADaM, DEFINE.XML).
  • Clinical trial data management and regulatory compliance.
  • SOP development and process standardization.
  • Mentoring and team leadership.
  • Regulatory submission experience.
  • Problem-solving and analytical thinking.
  • Communication and presentation skills.
  • Cross-functional collaboration.

 

Why Choose Us?

 

At our organization, we offer a dynamic work environment that fosters growth and development. Our commitment to innovation and excellence has earned us a reputation as a leader in our field. Join our team and be part of something big

 

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