Principal Statistical Programmer
Company Name:
Millennium Pharmaceuticals
-RDP 294:Start->
JOB TITLE Principal Statistical Programmer
Requisition Number 7716BR
Department Name Global Statistics
Location Cambridge, MA
Job Description Position
Summary:
The purpose of this position is to provide advanced therapeutic area/development phase statistical programming expertise and leadership, as well as broad technical expertise and influence in the TDC statistical programming area by:
oDesigning and creating analysis deliverables to meet the requirements of complex clinical studies, global development programs, or integrated safety analyses using efficient programming techniques that can serve as example for other projects
oFor assigned projects, (including regulatory submissions), managing and enforcing derived data and analysis output standards that maximize global data integratability and inter-program efficiency
oProviding project level and broader therapeutic area oversight to the work performed by external vendors to achieve quality and timely, cost-effective study deliverables
Duties and
Responsibilities:
oRepresent Statistical Programming in support of assigned clinical studies, global development programs and integrated analyses
oProvide leadership at the project and therapeutic area levels on the design and implementation of standards that support statistical analysis and reporting, including integrated analyses and summaries, and electronic submissions
oProvide statistical programming leadership in preparation of large and particularly complex regulatory submissions of clinical data and related documents and in supporting regulatory agency reviews
oServe as a subject matter expert and internal consultant for statistical programming on programming methods and techniques, and as a technical thought leader for the statistical programming area
oPartners with Statistics to ensure statistical programming deliverables correctly designed and executed according to statistical analysis goals, plans and methodologies
oIndependently develop, execute, and maintain SAS? computer programs, including complex macro programs, according to Statistical Analysis Plans (SAPs), cross-study analysis and data specifications, or analysis requests to:
-Produce statistical analysis output (tables, listings and graphs) involving descriptive and inferential statistics to support creation of the clinical study reports, integrated results, including safety statistics deliverables and regulatory submissions, and ad-hoc and exploratory analyses
-Perform data manipulations, including creation of derived data sets, related to the production of the statistical output
-Verify (QC) analysis results or derived data sets produced by another TDC statistical programmer, statistician, or an external vendor
oCoordinate work and provide guidance on technical and project management issues to Statistical Programmers, Senior Statistical Programmers and contractors, as appropriate, assigned to the same project
oIdentify vendor requirements and participate in the evaluation/selection of Analytical Science vendors. Contribute to defining technical aspects of the statistical programming sourcing model and vendor strategy and ensure consistency in vendor management for assigned projects for the statistical programming part. Provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs and consistency within development programs or integrated safety analyses. Review and approve key statistical programming vendor deliverables.
oIn collaboration with representatives from other AnSci departments participates in defining standards and standard processes for analysis and reporting. Proactively suggest improvements to processes, standards and utilities related to statistical programming and support their development and implementation to increase efficiency and enhance quality.
oDefine and manage transfers of all externally produced analysis data and outputs and archive statistical outputs and related documentation according to TDC standards
oRepresent Statistical Programming in relevant AnSci and cross-functional task forces and initiatives
oActively participate in external professional activities and organizations, such as CDISC, SAS Users Groups, etc.
oComply with all applicable regulatory requirements and Takeda standards and procedures
Qualifications:
oMS in Statistics, Computer Science, or other related field with a minimum of 8 years of SAS programming experience in the pharmaceutical/CRO industry; or BS in Computer Science, Statistics, or other related field with a minimum of 12 years experience. MS preferred.
oExpert level knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, strong knowledge of common procedures in SAS/STAT. Good knowledge of SAS technologies and products related to transformation, integration and analysis of clinical data.
oStrong knowledge of general programming and computing principles, solid technical expertise with Windows NT and/or UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise in office software (Microsoft Office?)
oGood knowledge of clinical study documents (protocol, CRF, SAP, Clinical Study Report)
oGood working knowledge of clinical study designs, statistical methodologies used in clinical trials, descriptive and inferential statistics, and data presentation practices
oStrong knowledge of data management processes, including EDC processes, documents and data flow in clinical trials
oGood understanding of drug development process
oStrong knowledge of FDA, EMEA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions, e.g. CDISC standards. Good understanding of regulations on computerized systems used in clinical trials
oStrong project management skills
oGood oral and written communications skills
Takeda provides equal employment and affirmative action opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.Estimated Salary: $20 to $28 per hour based on qualifications.
Millennium Pharmaceuticals
-RDP 294:Start->
JOB TITLE Principal Statistical Programmer
Requisition Number 7716BR
Department Name Global Statistics
Location Cambridge, MA
Job Description Position
Summary:
The purpose of this position is to provide advanced therapeutic area/development phase statistical programming expertise and leadership, as well as broad technical expertise and influence in the TDC statistical programming area by:
oDesigning and creating analysis deliverables to meet the requirements of complex clinical studies, global development programs, or integrated safety analyses using efficient programming techniques that can serve as example for other projects
oFor assigned projects, (including regulatory submissions), managing and enforcing derived data and analysis output standards that maximize global data integratability and inter-program efficiency
oProviding project level and broader therapeutic area oversight to the work performed by external vendors to achieve quality and timely, cost-effective study deliverables
Duties and
Responsibilities:
oRepresent Statistical Programming in support of assigned clinical studies, global development programs and integrated analyses
oProvide leadership at the project and therapeutic area levels on the design and implementation of standards that support statistical analysis and reporting, including integrated analyses and summaries, and electronic submissions
oProvide statistical programming leadership in preparation of large and particularly complex regulatory submissions of clinical data and related documents and in supporting regulatory agency reviews
oServe as a subject matter expert and internal consultant for statistical programming on programming methods and techniques, and as a technical thought leader for the statistical programming area
oPartners with Statistics to ensure statistical programming deliverables correctly designed and executed according to statistical analysis goals, plans and methodologies
oIndependently develop, execute, and maintain SAS? computer programs, including complex macro programs, according to Statistical Analysis Plans (SAPs), cross-study analysis and data specifications, or analysis requests to:
-Produce statistical analysis output (tables, listings and graphs) involving descriptive and inferential statistics to support creation of the clinical study reports, integrated results, including safety statistics deliverables and regulatory submissions, and ad-hoc and exploratory analyses
-Perform data manipulations, including creation of derived data sets, related to the production of the statistical output
-Verify (QC) analysis results or derived data sets produced by another TDC statistical programmer, statistician, or an external vendor
oCoordinate work and provide guidance on technical and project management issues to Statistical Programmers, Senior Statistical Programmers and contractors, as appropriate, assigned to the same project
oIdentify vendor requirements and participate in the evaluation/selection of Analytical Science vendors. Contribute to defining technical aspects of the statistical programming sourcing model and vendor strategy and ensure consistency in vendor management for assigned projects for the statistical programming part. Provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs and consistency within development programs or integrated safety analyses. Review and approve key statistical programming vendor deliverables.
oIn collaboration with representatives from other AnSci departments participates in defining standards and standard processes for analysis and reporting. Proactively suggest improvements to processes, standards and utilities related to statistical programming and support their development and implementation to increase efficiency and enhance quality.
oDefine and manage transfers of all externally produced analysis data and outputs and archive statistical outputs and related documentation according to TDC standards
oRepresent Statistical Programming in relevant AnSci and cross-functional task forces and initiatives
oActively participate in external professional activities and organizations, such as CDISC, SAS Users Groups, etc.
oComply with all applicable regulatory requirements and Takeda standards and procedures
Qualifications:
oMS in Statistics, Computer Science, or other related field with a minimum of 8 years of SAS programming experience in the pharmaceutical/CRO industry; or BS in Computer Science, Statistics, or other related field with a minimum of 12 years experience. MS preferred.
oExpert level knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, strong knowledge of common procedures in SAS/STAT. Good knowledge of SAS technologies and products related to transformation, integration and analysis of clinical data.
oStrong knowledge of general programming and computing principles, solid technical expertise with Windows NT and/or UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise in office software (Microsoft Office?)
oGood knowledge of clinical study documents (protocol, CRF, SAP, Clinical Study Report)
oGood working knowledge of clinical study designs, statistical methodologies used in clinical trials, descriptive and inferential statistics, and data presentation practices
oStrong knowledge of data management processes, including EDC processes, documents and data flow in clinical trials
oGood understanding of drug development process
oStrong knowledge of FDA, EMEA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions, e.g. CDISC standards. Good understanding of regulations on computerized systems used in clinical trials
oStrong project management skills
oGood oral and written communications skills
Takeda provides equal employment and affirmative action opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.Estimated Salary: $20 to $28 per hour based on qualifications.
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