Senior Statistical Programmer

General Summary

Under the general supervision of a Statistics Project Manager or higher, the Senior Statistical Programmer Analyst prepares analysis programs to support the preparation and statistical analysis of clinical data, coordinates the statistical programming activities for multiple clinical projects, ensures internal consistency of output, and assesses consistency with other projects and activities.

Specific Duties and Responsibilities

• Following specifications, develops algorithms and writes programs to create datasets.
• Produces data listings, summary tables and graphs using analysis software.
• Independently checks data listings, summary tables and graphs.
• Imports and exports data.
• Assists data management group in performing data edit checks to facilitate data cleaning.
• Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
• Prepares clinical trial datasets and programs for regulatory submission.
• Following statistical analysis plan, writes specifications for analysis datasets.
• Interacts with the project statistician and other programmers participating on a project team.
• Manage the data warehouse used to manage libraries of clinical study data.
• Interact with regulatory affairs, quality assurance staff, and external clinical system vendors.
• Mentors less experienced statistical programmers.
• Act as the subject matter expert on CDISC and good statistical programming practices.
• Builds efficient SAS coding and macro libraries.
• Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in statistics, computer science, or similar quantitative field, with 5+ years statistical programming experience and 3+ years of experience in clinical statistical programming within medical device or a related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)), or an equivalent combination of relevant education and applicable job experience may be considered

Additional qualifications:

• Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT
• SAS Certified Base and/or Advance Programmer experience is preferred
• Experience with macro programming and SAS/SQL a plus
• Good communication skills and attention to detail are crucial
• Proven ability to handle multiple tasks
• Able to identify ways to improve business performance and campaigning for it when necessary
• Knowledge of international regulations, requirements and guidance associated with clinical data standards and clinical databases used for regulatory submission
• Knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology
• Experience with metadata repository in clinical data a plus
• Experience with regulatory submissions a plus
• Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE
• Expertise at using SAS in Data Import (extracting the raw data from data warehouse with SAS/ACCESS and performing data pre-processing for particular statistical analysis), Data Manipulation (using SAS data step)