BioSpace
Director, Statistical Programming Lead
BioSpace, King Of Prussia, Pennsylvania, United States, 19406
Overview
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Director, Statistical Programming Lead
role at
BioSpace . CSL's R&D organization is accelerating innovation to deliver greater impact for patients. This is a hybrid position in King of Prussia, PA, onsite three days a week. You will report to the Senior Director Programming. You will provide leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities to meet regulatory obligations. You will manage a team of programmers supporting clinical trials and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas. You will work closely with the Senior Director, Clinical and Statistical Programming and with Statisticians to ensure deliverables are accurate and aligned with CSL standards. Responsibilities
Working with the Biometrics Programming Leadership team, assess upcoming activities and resource needs and allocate projects to ensure high quality, timely delivery. Ensure realistic resource planning. Oversee the CRO delivery or manage in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analyses. Coordinate oversight of in-house programming of exploratory analyses, analyses to support secondary publications, regulatory responses, or other ad hoc requests. Manage, hire, and mentor direct reports including annual evaluations and goal setting. As a member of the programming leadership team within biometrics, create and maintain programming processes and strategy to facilitate accurate and timely analysis programming. Help bring state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI. Qualifications And Experience Requirements
BSc in Computer Science, Mathematics, Statistics or related area with relevant experience At least 15 years of experience in the biotech, pharma, or CRO industries Preferred 5 or more years of direct supervisory experience Experience with CRO management and/or CRO work experience Extensive understanding of clinical programming and/or statistical programming processes and standards Advanced experience with SAS programming, including development and use of SAS Macros; preferred experience managing teams Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. Our benefits support health care to financial protection and include resources to help employees and their families. CSL has many benefits to help achieve goals at every life stage. Please review our benefits site for details. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas using three strategic platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. CSL Behring operates CSL Plasma, one of the world’s largest plasma collection networks. Our parent company, CSL, employs 32,000 people and serves patients in more than 100 countries. Inclusion and Belonging is at the core of our mission and who we are. By celebrating differences and fostering a culture of curiosity and empathy, we aim to connect with patients and donors and sustain a diverse workforce for the future. Learn more about Inclusion and Belonging. Job postings and related information
We encourage you to review related opportunities and apply for roles in the King of Prussia, PA area. Examples include: Director of Enterprise Reporting & Analytics, Senior Manager, Business Intelligence and Analytics, Digital Analytics Manager with Pharma experience, and other analytics roles in Philadelphia, PA and surrounding areas.
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Join to apply for the
Director, Statistical Programming Lead
role at
BioSpace . CSL's R&D organization is accelerating innovation to deliver greater impact for patients. This is a hybrid position in King of Prussia, PA, onsite three days a week. You will report to the Senior Director Programming. You will provide leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities to meet regulatory obligations. You will manage a team of programmers supporting clinical trials and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas. You will work closely with the Senior Director, Clinical and Statistical Programming and with Statisticians to ensure deliverables are accurate and aligned with CSL standards. Responsibilities
Working with the Biometrics Programming Leadership team, assess upcoming activities and resource needs and allocate projects to ensure high quality, timely delivery. Ensure realistic resource planning. Oversee the CRO delivery or manage in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analyses. Coordinate oversight of in-house programming of exploratory analyses, analyses to support secondary publications, regulatory responses, or other ad hoc requests. Manage, hire, and mentor direct reports including annual evaluations and goal setting. As a member of the programming leadership team within biometrics, create and maintain programming processes and strategy to facilitate accurate and timely analysis programming. Help bring state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI. Qualifications And Experience Requirements
BSc in Computer Science, Mathematics, Statistics or related area with relevant experience At least 15 years of experience in the biotech, pharma, or CRO industries Preferred 5 or more years of direct supervisory experience Experience with CRO management and/or CRO work experience Extensive understanding of clinical programming and/or statistical programming processes and standards Advanced experience with SAS programming, including development and use of SAS Macros; preferred experience managing teams Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. Our benefits support health care to financial protection and include resources to help employees and their families. CSL has many benefits to help achieve goals at every life stage. Please review our benefits site for details. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas using three strategic platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. CSL Behring operates CSL Plasma, one of the world’s largest plasma collection networks. Our parent company, CSL, employs 32,000 people and serves patients in more than 100 countries. Inclusion and Belonging is at the core of our mission and who we are. By celebrating differences and fostering a culture of curiosity and empathy, we aim to connect with patients and donors and sustain a diverse workforce for the future. Learn more about Inclusion and Belonging. Job postings and related information
We encourage you to review related opportunities and apply for roles in the King of Prussia, PA area. Examples include: Director of Enterprise Reporting & Analytics, Senior Manager, Business Intelligence and Analytics, Digital Analytics Manager with Pharma experience, and other analytics roles in Philadelphia, PA and surrounding areas.
#J-18808-Ljbffr