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:
Responsible for aligning technology solutions, such as Robotic Process Automation (RPA), Machine Learning (ML), and Artificial Intelligence (AI), and statistical software with Statistics and Statistical Programming business strategies
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Acts as the primary business contact and Subject Matter Expert for the IT organization for systems implementation and maintenance.
TABLES, LISTINGS, GRAPHS, NARATIVE, ETC. CREATION SAS Programming:
Demonstrated extensive understanding of SAS programming concepts and techniques.
Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations
Ensure internal consistency of output and assess consistency with other activities for the project, as applicable
Leads effort to determine and implement standards related to analysis and statistical programming conventions. 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
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
Responsible for assessing the validation requirements for all Statistical Software and IT systems. Works with IT to ensure system validation has been completed and documentation is complete.
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
Responsible for the creation and accuracy of integrated data set
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
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 ensur
They are appropriate to support project objectives
Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specification.
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 program
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
Maintain expertise in the use of the UNIX utilities
Responsible for developing new utilities, as well as, presenting information on existing utilities
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
Identifies alternative solutions, assesses feasibility and makes recommendations to exploit/leverage new or existing IT technology.
Maintain expertise in the use of the SAS Macro
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
Work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission
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
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
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 Assists management in technical training, guiding and evaluating technologies 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
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 programmer
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
Hands on experience in incorporating RPA, ML, and AI solutions into existing processes
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 Additional Information
Significant Work Activities and Conditions: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced
Associated topics: biostatistics, data analyst, probability, statistics, c
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.