Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
PRIMARY JOB FUNCTION:
Provide statistical programming support for multiple clinical projects or therapeutic areas.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
TABLES, LISTINGS, GRAPHS, NARRATIVE, ETC., CREATION
SAS Programming: Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply 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: Contribute to the determination of project standards related to output design and statistical programming conventions, and, with supervision, ensure they are appropriate to support project objectives.
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 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.
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 project conventions and with verifying that conventions are followed.
Database Quality Assurance: Ensure accuracy of database quality assurance checks and assess data accuracy and consistency.
Develop database checks for routine and with supervision develop checks for non-routine situations.
Derivation Programming: Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
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.
Submission Data Sets and Programs: 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. Responsible for ensuring peer review for all submission data sets and programs for the assigned projects.
PROCESSES, UTILITIES AND MACROS
Unix Utilities: Maintain expertise in the use of the UNIX utilities. Participate in 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. Participate in the development of new processes.
SAS Macros: Maintain expertise in the use of the SAS Macros. Participate in the development of new SAS Macros. Responsible for formulating proposals for SAS Macros, as well as, presenting information on existing 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. Guide clients on possible options for deliverables for non-routine requests.
Communication: Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles.
TRAINING, MENTORING, SUPERVISING, PROJECT COORDINATION
Training and Mentoring: Be 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.
Project Coordination: 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. Appropriately delegate assignments and reviews deliverables so that projects are delivered on time with suitable quality.
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. Coordinates the statistical programming activities for 0-3 clinical projects.
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.
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.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Yes, 20 % of the Time
Abbott Laboratories - 2 years ago
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