Manager, Statistical Programming

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Feb 20, 2018
Ref
1607811
Required Education
Bachelors Degree
Position Type
Full time


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

Qualifications:



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