Clinical Statistical Programmer

General Summary

Under general supervision of a Statistics Project Manager or higher, prepares analysis programs to support the preparation and statistical analysis of clinical data. Works closely with other programmers, biostatisticians, and clinical data managers, with a leading role in the collection, analysis, and reporting of clinical data for trials.

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 the data management group in performing data edit checks to facilitate data cleaning.
• • Maintains a 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 the statistical analysis plan, writes specifications for analysis datasets.
• • Interacts with the project statistician and other programmers participating on a project team.
• • Manages the data warehouse used to manage libraries of clinical study data.
• • Interacts with regulatory affairs, quality assurance staff, and external clinical system vendors.
• • Mentors less experienced statistical programmers.
• • Acts 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.
• • Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• • Ensures other members of the department follow the QMS, regulations, standards, and procedures.
• • Performs other work-related duties as assigned.

Position Qualifications

Minimum Education and Experience:

• Bachelor's degree in Statistics, Computer Science, or a related field with 5+ years of statistical programming experience, including 3+ years of experience in clinical statistical programming within the medical device or related industry (e.g., biotechnology, pharmaceutical, Clinical Research Organization (CRO)).

Additional Qualifications:

• • Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.
• • SAS Certified Base and/or Advanced Programmer experience is preferred.
• • Experience with macro programming and SAS/SQL is a plus.
• • Proven ability to handle multiple tasks.
• • Ability to identify ways to improve business performance and advocate for them 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 is a plus.
• • Experience with regulatory submissions is a plus.
• • Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE.
• • Expertise in using SAS for data import (extracting raw data from data warehouse with SAS/ACCESS), data manipulation (using SAS data steps and PROCs), and data analysis (PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TTEST, PROC GLM, PROC LOGISTIC, PROC LIFETEST, PROC PHREG).
• • Data export: generate output with PROC REPORT, PROC SGPLOT, SAS/ODS; Graphs (Kaplan-Meier plot, box plot, bar chart, waterfall plot, forest plot, shift plot, life table, prevalence plot, etc.).
• • Proficient in developing SAS/MACROS to access, extract, modify, merge, and analyze clinical data.
• • Strong oral, written, and interpersonal communication skills required.
• • High degree of accuracy and attention to detail.
• • Proficiency with MS Word, Excel, and other standard office tools.

Working Conditions

General office environment. Frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer for extended periods. Specific vision abilities required include reading, close vision, distance vision, color vision, peripheral vision, and depth perception. Approximately 10% travel to conferences and/or other Penumbra-affiliated facilities.