Senior Statistical Analyst
- The Statistical Programming group is a part of Data and Statistical Sciences (DSS) and is responsible for providing statistical programming services to the Global Pharmaceutical Research and Development division (GPRD). These services are supplied in the context of a cooperative and project-oriented effort with the Global Project Teams (GPTs) and Product Safety teams (PSTs) in the summarization and reporting of data from clinical trials. These services also include the summarization of aggregate data and creation of submission documents to be provided to regulatory agencies. We have an exciting opportunity for a Principal Statistical Analyst based in North Chicago, IL reporting to the Senior Manager, Statistical Programming. Key Responsibilities:•Provide statistical programming support for multiple clinical projects or therapeutic areasTABLES, LISTINGS, GRAPHS, NARATIVE, ETC. CREATION SAS Programming: •Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry•Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations Consistency:•Ensure internal consistency of output and assess consistency with other activities for the project, as applicable
Standards:•Leads effort to determine project standards related to output design and statistical programming conventions and independently ensure they are appropriate to support project objectives•Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional 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•Determine the scope of the peer review and for ensuring peer review has been completed for all activities for the assigned projectsArchival of SAS Programs:•Ensure all SAS programs are imported into the archive system prior to the creation of final output and all programs are formally archived after the completion of the regulated activity
DATABASE ACTIVITIES•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•Review for consistency across studies within a project•Assist with developing global CRF and database standards
Database quality assurance:•Ensure accuracy of database quality assurance checks and assess data accuracy and consistency•Develop database checks for routine and non-routine situations•Participate in the development of standard data quality assurance tools
Derivation Programming:•Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications•Responsible for the creation and accuracy of derivation programs for routine and non-routine situations•Ensure peer review has been completed for all derivation programs for assigned projects
Submission Data Sets and Programs:•Responsible for the creation and accuracy of submission data sets and analysis programs and the creation of data definition documents•Ensure peer review for all submission data sets and programs for the assigned projects•Monitor regulatory guidance and industry best practices to formulate proposals for new functional standards for submission data sets and programs PROCESSES, UTILITIES AND MACROS•Unix Utilities: Maintain expertise in the use of the UNIX utilities. Oversee the development of new UNIX utilities.•Responsible for formulating proposals for new utilities, as well as, presenting information on existing utilities.
Process Improvements: •Responsible for identifying opportunities for productivity improvements and formulating implementation plans. Design and develop various software and systems to effectively generalize programming effort across projects.SAS Macros:•Maintain expertise in the use of the SAS Macros. Oversee the development of new SAS Macros. Responsible for formulating proposals for SAS Macros, as well as, presenting information on existing Macros. CONSULTATIONTeamwork: 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. Guide clients on possible options for deliverables for non-routine requests. Responsible for developing and maintaining good client relationships. Effectively represent the Statistical Programming organization on cross functional initiative teams.Communication: •Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists.•Communicates an understanding of clinical principles, regulatory standards, and drug development principles, and act in accordance with those principles.•GPT Involvement: Represents the Statistical Programming Organization on Study Teams and be adhoc participant on PST teams. TRAINING, MENTORING, SUPERVISING, PROJECT COORDINATION•Ensures that self and staff are compliant with training requirements. Effectively mentor non-statistical programming peers with regard to statistical programming practices. •Effectively mentor statistical programming and non-statistical programming peers with regard to functional operations. •Train new statistical programmers on statistical programming practices. Provide presentations on statistical programming topics to the statistical programming organization. Project Coordination: •Coordinate the statistical programming activities for 1-4 clinical projects within or across therapeutic areas. •Oversee the work of 0-5 Statistical Programmers/Senior Statistical Programmers or contractors. Appropriately delegate assignments and reviews deliverables so that projects are delivered on time with suitable quality. Performance Management: •Provide all performance management activities for 0-5 statistical programmers
Position will be hired based on experience.
For Senior Statistical Analyst:
- MS in Statistics, Computer Science or a related field with 6+ years of relevant experience OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience
- High degree of technical competence and communication ability, both oral and written
- Competent in SAS programming and Macro development
- Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA
- NDA/BLA or other regulatory filing experience, including ISS or ISE experience