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Sr. Statistical Programmer

Department: Clinical
Location: Cambridge, MA

Sr. Statistical Programmer

Summary of Position

The Sr. Statistical Programmer is responsible for designing, developing, validating, and maintaining data sets and tables, listings and figures (TLFs), for reporting, general purpose and ad hoc SAS programs used in the support of regulatory submission of clinical trials, or internal decision making relative to clinical trial conduct. This role provides expertise in SAS programming and related processes to the Biostatistics group, and requires profound working knowledge of CDISC SDTM, ADAM, Define.xml structures and standards, as well as working knowledge of ICH and FDA guidelines on data and reporting standards. The Sr. Statistical Programmer may also assist in developing strategies and methodologies for ensuring that all programming is accurate and complies with regulatory requirements, and helps develop appropriate SOPs for the programming and other departmental processes. 


Primary responsibilities

  • Validate tables, listings, and figures per protocol and statistical analysis plan generated by external vendors
  • Generate tables, listings, figures and datasets for ad-hoc requests from clinical development department and other functional areas
  • Validate SAS programs written by others
  • Assist management in maintaining SOPs and work instructions relevant to SAS programming.
  • Follow regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions.
  • Responsible for the on-time and accurate completion of duties assigned.
  • Write and maintain documentation to describe program development, logic, coding, testing, and updating.
  • Support departmental archiving of computer programs, data, and documentation.
  • Create and execute SAS programs to extract data from databases and create analysis-ready SAS datasets.
  • Convert external data to SAS datasets for internal use.
  • Design robust, flexible, and modular macros for projects.
  • Assist in timeline set up and ensures that programming activities are implemented consistently across clinical studies

Minimum Requirements

Education:

Bachelorís degree required. Masterís degree in Computer Science, Computer Information Systems, Statistics, Engineering, or a related field preferred.


Preferred Skills/Qualifications: 

  • 6+ years of SAS programming experience in Pharmaceutical environments. 
  • In-depth knowledge of CDISC SDTM, ADaM, Define.xml, CFR 21 Part 11 compliance, ICH and FDA standards      preferred.
  • Strong knowledge of BASE/SAS, SAS Macros, ODS and SAS/Graph in a Windows SAS environment.
  • Knowledge of data manipulation, report generation in support of regulatory submission.
  • Understanding of data and system dependencies, validation techniques, and integration of studies for ISS/ISE.
  • Knowledge of MS-Office (i.e. Word, Excel and PowerPoint)
  • Technical writing skills adequate to prepare effective documentation for programs and contribute to SOP development.
  • Effective interpersonal skills in collaborating with teams composed of individuals with widely diverse      backgrounds, skill levels, and organizational levels.

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