Senior Statistical Programmer
Grand Rapids, Michigan
JOB DESCRIPTION SUMMARY
The Senior Statistical Programmer is responsible for performing assigned statistical programming activities for the company. Activities must meet schedules and projected allocated hours, adhere to relevant standard operating procedures (SOPs), and meet the statistical requirements of the company as well as the company’s clients.
- Master’s degree (M.S., M.A.), preferably in Statistics, or equivalent
o At least 6 years clinical trial experience
- Bachelor’s degree (B.S., B.A.), preferably in Statistics, or equivalent
o At least 8 years clinical trial experience
- Proficient in SAS with a strong knowledge of statistical procedures.
- Advanced knowledge of Quality Control (QC) clinical trial programming practices.
- Intermediate understanding of applied statistics and basic understanding of statistical theory.
- Basic knowledge of clinical research and Good Clinical Practice (GCP).
- In-depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) regulatory requirements and related guidance documents.
- Independent SAS research skills.
- SAS Advanced Programming certification within 6 months of hire or 4 years prior experience programming in SAS.
- Read, analyze, interpret, write, and explain technical procedures and SAS programming requirements.
- Read, analyze, interpret, and explain SAS programs written by others.
- Clearly and effectively communicate, verbally, in writing, and in presentations, facts, concepts, ideas.
- Exhibits good listening skills and appropriately solicits information and/or advice from others.
- Write routine, special, and technical documentation and correspondence
- Strong interpersonal skills with ability to collaborate effectively with other groups and maintain effective working relationships with colleagues and partners.
- Ability to perform directed programming research.
- Ability to work with minimal supervision.
- Ability to look for ways to streamline, change and/or standardize processes resulting in savings in time and/or process cost or different ways/methods to achieve results that would improve processes (shorten timelines, overcome “bottlenecks” in critical paths).
RESPONSIBILITIES & PRINCIPAL DUTIES
- Perform assigned programming and statistical analysis activities, including meeting schedules, adhering to relevant SOPs, complying with regulatory requirements, and confirming the quality of the deliverable product.
- Prepare and implement randomization plans.
- Convert/QC conversion data from external sources to datasets to be used internally.
- Create/QC SAS datasets and associated documentation for internal use and for regulatory submission (e.g., CDISC Study Data Tabulation Model [SDTM] and Analysis Data Model [ADaM]).
- Annotate/QC annotation of case report forms (CRFs) for submission datasets and publishing of annotated CRFs.
- Create/QC define documentation (define.PDF, define.XML) for submission datasets and publish define documents (where applicable).
- Perform/QC statistical analysis (implement specified analyses in statistical documents (e.g., statistical analysis plans [SAPs], programming notes).
- Prepare programming notes from statistical documents (e.g., SAPs).
- Review SAP text and prepare mock table, figure, and listing shells for SAPs.
- Produce/QC tables, figures, listings from mock shells (e.g., in SAPs, programming notes).
- Review CRFs and electronic CRFs (eCRFs) for programming implementation.
- Review point of entry (paper or EDC) system CRF annotations for programming implementation.
- Design/review/QC EDC export specifications.
- Review EDC data export downloads for compliance with export specifications.
- Perform EDC user acceptance testing (UAT) for programming implementation.
- Maintain awareness of developments (e.g., version differences, enhancements, changes) within SAS software.
- Serve as member of or lead statistical programming efforts for internal project teams.
- Collaborate with Associate Manager of Statistical Programming on process development, contributing to department advancement.
- Lead key departmental goals and initiatives.
- Lead or participate in employee training within the statistical services group.