• United States Of America, Usa
  • Save Job
  • 7 - 10 Years
  • Posted : above 1 month

Job Description:

The Principal Statistical Programmer role has heavy emphasis on delivery while also focusing on leading a clinical program utilizing project management and technical leadership abilities This role is responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members This position requires high degree of independence, technical skills and ability to influence the team to get results without line management authority

Major Responsibilities

Review a clinical study protocol with regard to statistical programming responsibilities
Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP)
Review and provide input to Case Report Forms (CRFs) and external data transfer agreements
Work cooperatively with and hold accountable clinical study team members including but not limited to the biostatistician, data manager, and medical writer
Work cooperatively with and oversee a contract programming provider
Assign tasks, set priorities, and provide technical help to clinical study programming teams
Develop and maintain SDTM and ADaM specifications
Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications
Understand and enforce compliance with MedImmune programming standards and data standards in clinical study programming teams
Provide accurate programming time estimates and risk mitigation plans to management or a study team
Proactively inform management of the status of statistical programming deliverables and issues
Oversee on-time delivery from clinical study programming teams and meet timelines for multiple concurrent studies
Contribute to or initiate standards or process improvements

Required Skills

Excellent SAS programming skills; contribute programming to a global library of macros
Able to communicate clearly in oral or written form
Advanced knowledge of CDISC standards and applying standards to complicated data
Advanced knowledge of lab data processing and able to resolve issues
Working knowledge of medical terms, the data coding process, and coding dictionaries
Apply regulatory agency guidance in statistical programming responsibilities

Preferred Skills

Able to program in other languages (eg R or S-PLUS, VBA, or Perl)
Advanced knowledge of Unix commands; able to program shell scripts for complicated tasks
Advanced knowledge of inferential statistics


Education Minimum Bachelors Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field

Experience A minimum 5 years of SAS programming in clinical studies including leading a clinical study programming team For Sr Principal a minimum of 7 years statistical clinical study programming

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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Teaching/Education
Role : Teacher
Salary : As per Industry Standards
Deadline : 01st Apr 2020

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