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Manager, Statistical Programming

Manager, Statistical Programming
USA, Illinois, Lake County
Information Technology
Requisition #1607811
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.
Primary Job Function:
+ Provide statistical programming support for multiple clinical projects or therapeutic areas
+ Provide performance management for 0-5 statistical programmers
Core Job Responsibilities:
+ Responsible for compliance with applicable Corporate and Divisional Policies and procedures
TABLES, 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
+ Responsible for determining the scope of the peer review and for ensuring peer review has been completed for all activities for the assigned projects
Archival of SAS Programs:
+ 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
DATABASE ACTIVITIES
Data Integration:
+ Responsible for the creation and accuracy of integrated data sets
+ Responsible for the creation and review of integrated data set specification
+ Responsible for ensuring peer review for all integrated data sets and programs for the assigned projects
Data Standards:
+ Demonstrated extensive understanding of CDISC SDTM and ADaM standards
+ Demonstrated extensive understanding of submission data requirements
+ Leads effort to determine project integrated data standards and independently ensure they are appropriate to support project objectives
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 on-routine situations
+ Responsible for ensuring 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
+ Responsible for the creation of data definition documents and TOCs
+ Responsible for ensuring peer review for all submission data sets and programs for the assigned projects
+ Responsible for monitoring 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
+ 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
+ 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
CONSULTATION
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
+ 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
+ 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
+ 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 Accountability / Scope
+ Accountable for providing Statistical Programming support for clinical trials
+ Collaborates primarily with other statistical programmers, statisticians, and data managers, as well as with clinical teams, to achieve study and project goals
+ Provide all performance management activities for 0-5 statistical programmers
Experience and Education Required:
+ MS in Statistics, Computer Science or a related field with 8+ years of relevant experience OR BS in Statistics, Computer Science or a related field with 10+ 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
+ Thorough understanding of ICH Guidelines and relevant regulatory requirements
+ Project lead experience required. Management experience not required
Key Leadership Competencies:
+ Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
+ Learns fast, grasps the 'essence' and can change the course quickly where indicated
+ Raises the bar and is never satisfied with the status quo
+ Creates a learning environment, opens to suggestions and experimentation for improvement
+ Embraces the ideas of others, nurtures innovation and manages innovation to reality
Equal Opportunity Employer Minorities/Women/Veterans/Disabled


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