Provide statistical programming support for the reporting of clinical trial results. Key Responsibilities Include:
- SAS Programming: Demonstrated practical understanding of SAS programming concepts and techniques.
Consistency: Review output to ensure internal consistency with other output for the activity (CSR, ISS, ISE, …)
Standards: Follow all department and project standards.
Validation of SAS Programs: Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and
running all checking utilities. Responsible for creating peer review programs for assigned studies.
- Archival of SAS Programs: Ensure all SAS programs are imported into the archive system prior to the creation of final output.
- Case Report Forms and Database Definitions: Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions,
and specifications for analysis data sets for individual studies
- Database Quality Assurance: Ensure accuracy of database quality assurance checks and assess data accuracy and consistency. Develop
database checks for routine situations.
- Derivation Programming: With supervision, responsible for the creation and accuracy of derivation programs for routine situations, including
Submission Data Sets and Programs: With supervision, responsible for the creation and accuracy of submission data sets and analysis
programs for routine situations. Responsible for the creation of data definition documents and TOCs.
- Unix Utilities: Learn and maintain expertise in the use of the UNIX utilities developed for the Statistical Programmers. Participate in the
development of new UNIX utilities.
- Process Improvements: Assist in the development of new processes and ensure all process improvements are implemented.
SAS Macros: Learn and maintain expertise in the use of the SAS Macros developed for the Statistical Programmers. Participate in the
development of new SAS Macros.
- Teamwork: Work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission.
Client Interaction: Provide accurate and timely responses to routine requests from clients. Discuss with supervisor to ascertain appropriate
understanding of non-routine requests.
- Training and Mentoring: Be compliant with training requirements. Effectively mentor statistical programming peers with regard to functional
Project Coordination: Coordinate the statistical programming activities for 0-2 early stage clinical projects in the same therapeutic area.
- Accountable for providing statistical programming support for reporting of clinical trials, in collaboration with other statistical programmers,
statisticians, and data managers.
- MS in Statistics, Computer Science or a related field. OR BS in Statistics, Computer Science or related field with 2+ years of relevant
- Sound technical skills and communication ability, both oral and written. Competent in SAS programming.