- CREATION OF TABLES, LISTINGS, GRAPHS, NARRATIVE, ETC.
- Accountable for providing Statistical Programming support for clinical trials by collaborating primarily with other statistical programmers, statisticians, and data managers, as well as with clinical teams, to achieve study and project goals.
- Ensure all SAS programs are imported into the archive system prior to the creation of final output. Ensure all programs are formally archived after the completion of the regulated activity. Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies. Review for consistency across studies within a project. Assist with developing project conventions and verifying that conventions are followed.
- Develop database checks for routine and with supervision develop checks for non-routine situations. Be compliant with training requirements.
- Responsible for the creation and accuracy of derivation programs for routine and with supervision create derivation programs for non-routine situations. Responsible for ensuring peer review has been completed for all derivation programs for assigned projects.
- Responsible for the creation and accuracy of submission data sets and analysis programs for routine situations and with supervision for non-routine situations. Responsible for the creation of data definition documents and TOCs and for ensuring peer review for all submission data sets and programs for the assigned projects.
- Participate in the development of new UNIX utilities; responsible for formulating proposals for new utilities, as well as, presenting information on existing utilities. Participate in the development of new SAS Macros; responsible for formulating proposals for SAS Macros, as well as, presenting information on existing Macros.
- Participate in the development of new processes and provide accurate and timely responses to routine requests from clients and guide clients on possible options for deliverables for non-routine requests.
- Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles. Effectively mentor non-statistical programming peers with regard to statistical programming practices and mentor statistical programming/non-statistical programming peers with regard to functional operations.
- Coordinate the statistical programming activities for 0-3 clinical projects within the same therapeutic area. Oversee the work of 0-3 Statistical Programmers/Senior Statistical Programmers or contractors.
- MS in Statistics, Computer Science or a related field with 3+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 5+ years of relevant experience.
- High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development.
- Pharmaceutical or related industry experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
- Demonstrated practical understanding of SAS programming concepts and techniques appropriate to pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge to solve problems related to non-routine situations.
- Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
- Expertise in the use of UNIX utilities and SAS Macros
- Ability to work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission.
- Ability to appropriately delegate assignments and review deliverables so that projects are delivered on time with suitable quality.
- Ability to identify opportunities for productivity improvements and formulate implementation plans.
- Ability to contribute to the determination of project standards related to output design and statistical programming conventions, and, with supervision ensures they are appropriate to support project objectives.
Significant Work Activities: N/A
Job Type: Experienced