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Sr. Statistical Programmer

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Newton, MA
$110,000 - $150,000
Job Type
Direct Hire
Nov 18, 2016
Job ID
Position Summary 
The Sr. Statistical Programmer demonstrates quality in all actions; Works in partnership with Biostatistics, Data Management and Clinical Operations to conduct statistical programming .  Develops SOPs for internal programming practices, oversees vendor activity associated with statistical programming services, contributes to clinical data reports for all IDE updates and submissions and interfaces with other departments within  (Marketing, Healthcare Economics, Clinical Engineering, etc.) for special programming needs.  The Senior Statistical Programmer will participate in preparing new clinical trial protocols.  In addition, the candidate will provide assistance in preparing manuscripts for publication and data summaries for professional meetings and for Board presentations.  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
Essential duties and responsibilities
A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
  • Collaborates with Biostatistics, Data Management and Clinical Operations in the design and development of protocols, statistical analysis plans, data management plans, and ensures programming integrity and compliance for data analyses and the reporting of results.
  • Prepares statistical programming components of regulatory submissions.
  • Is a highly skilled programmer who performs highly-complex programming, reviews Statistical Analysis Plans and Case Report Forms (CRFs), creates statistical report templates, and contributes to statistical programming standards.
  • Understands the clinical data acquisition and processing services provided by vendors.
  • Helps to define the internal process for validating and distributing data within the company and maintains a record of the source of distributed data for later confirmation if necessary.
  • Ensures integrity and regulatory compliance of all data analysis associated with in-house and outsourced clinical study databases, software, and raw analysis data files.
  • Contributes to the preparation of SOPs relevant to statistical programming and validation.
  • Performs miscellaneous job-related duties as assigned.
Required Knowledge, Skills, Abilities
  • Knowledge of medical records
  • Knowledge of randomized controlled clinical trials principles, methodology, and procedures
  • Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects
  • Ability to develop and deliver both oral and written presentations
  • Ability to establish data processing guidelines
  • Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment
  • Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
  • Skill in the use of computer statistical, technical, and database applications
  • Ability to work through a Contract Research Organization
Required Education/ Experience
  • Bachelor’s Degree in Statistics or related scientific field 
  • 5+ years of experience that is directly related to the duties and responsibilities specified. 
  • Candidate must be highly motivated, have excellent interpersonal and written communication skills, composed under stress and well organized. 
Preferred Experience
  • Master’s degree
  • Ability to develop technical analyses for reports and manuscripts
  • Experienced at effective presentation or meeting with FDA or other competent authority
  • Should have medical device experience – especially cardiovascular
  • Ability to independently develop novel concepts and techniques in regarding statistical programming
  • Broad knowledge of statistical data collection, editing, validation, and analysis techniques
  • Knowledge of the infrastructure and operational characteristics of contract research organizations