Statistician - Scientific III

Artech Information System LLC; Titusville (Crawford County); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading IT staffing company is seeking an Analysis Standards Associate to manage analysis standards for clinical research. Responsibilities include aligning standards with business needs, reviewing statistical datasets, and supporting stakeholders in implementing these standards. Candidates should hold a BS/BA in statistics and have over 5 years of experience in a biopharma environment, alongside solid SAS programming knowledge. This role also requires strong communication and organizational skills in a collaborative virtual team setting.

Qualifications

• 5+ years in a statistician role with clinical research analysis.
• Basic knowledge of SAS programming for QC/validation.
• Understanding of clinical research analysis principles.
• Strong understanding of regulatory requirements for clinical research.
• Excellent English verbal and written communication.
• Ability to work effectively in a virtual multi-project environment.

Responsibilities

• Define and maintain standard statistical requirements.
• Review standard datasets and metadata for compliance.
• Develop documentation on standards and processes.
• Develop, review and maintain documentation describing standards and related processes.
• Provide support for stakeholders including communications, training, QA, and usage metrics.
• Assist with coordination of standards development projects and change requests.
• Assist with maintenance of the standards repository.

Skills

SAS programming

Communication skills

Collaboration

Problem-solving skills

Education

BS/BA degree in statistics or related field

Tools

SAS programming

ADaM/SDTM knowledge

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

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