Statistician - Scientific III

Analysis Standards Associate - Statistician III Consultant

Correct Location- TITUSVILLE, NJ (System Error)

Summary

The Analysis Standards Associate provides operational expertise in developing and managing analysis standards for clinical research.

The role of the Analysis Standards Associate is to work with business stakeholders to align standards with business needs, provide standards guidance to content subject matter experts (SMEs) developing or updating standards content, review and QC standard SAS code, and support and align with relevant industry standards.

Key Responsibilities

Work with business stakeholders to define, review, QC, and maintain standard statistical requirements aligned with business needs and industry standards

Review and QC ADaM dataset and result metadata aligned with documented statistical requirements and industry standards

Review and QC SAS programs and macros that create standard ADaM datasets and tables, figures, and listings based on documented statistical requirements

Develop, review and maintain documentation describing standards and related processes and business rules

Provide support for business stakeholders implementing standards including communications, training, Q&A, compliance and usage metrics

Assist with coordination of standards development projects

Assist with management, assessment, and execution of change requests

Assist with maintenance of the standards repository

Qualifications and Competencies

BS/BA degree in statistics (preferred), computer science, mathematics, or other scientific field

5+ years as a statistician or similar position with clinical research analysis and reporting responsibility in a biopharma or CRO environment

Basic knowledge in SAS programming with experience developing programs for QC/validation purposes

Solid understanding of the principles and practices of clinical research analysis and reporting with Statistical Analysis Plan development experience

Basic knowledge of relevant industry standards (ie, ADaM and SDTM with focus on ADaM specifications experience ) and solid knowledge of regulatory requirements

Strong English verbal and written communication skills

Experience working in a virtual team environment with good collaboration, organizational, communication, and problem-solving skills

Ability to prioritize tasks and work effectively in a fast-paced multi-project environment

BS/BA degree in statistics (preferred), computer science, mathematics, or other scientific field

Regards,

Akriti Gupta

Associate Recruiter (Clinical / Scientific Division)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3409 | Fax: 973.998.2599

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