Alexion Pharmaceuticals, Inc.
Associate Director, Statistical Programming
Alexion Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Overview
Associate Director, Statistical Programming — Join to apply for the Associate Director, Statistical Programming role at Alexion Pharmaceuticals, Inc. The Associate Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. The candidate should have extensive experience with SAS in a Statistical Programming environment and a complete understanding of statistical programming processes, procedures, and roles. Knowledge of CDISC SDTM and ADaM standards is required to support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures and creating all files necessary to support an electronic submission in the eCTD format. The role also involves people management responsibilities, providing direct line management to the statistical programming team, identifying training needs, optimizing staff utilization, and managing the day-to-day activities of external partners to deliver program results.
You Will Be Responsible For
Lead Programmer and Manager of the statistical programming efforts, with responsibilities that may include additional duties.
Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs.
Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications.
Ensure filing of study documentation is maintained to the standard required by processes and audit requirements.
Directly support the Clinical and Statistical Programming Director in management and development of the Statistical Programming team; participate in process reviews and updates.
Create and/or review programming plans, ensure appropriate resource allocation and prioritization.
Act as primary department contact, when necessary, to ensure department standards are implemented in all studies.
Ensure adherence to company policies, SOPs, and controlled documents; align programming activities with departmental standards.
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions to address programming needs.
You Will Need To Have
7+ years of statistical programming experience in the CRO or Pharmaceutical Industry.
4+ years of project management experience in the CRO or Pharmaceutical Industry.
Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.
Strong people management and supervisory skills with experience leading cross-functional projects from concept to completion.
Strong verbal and written communication skills to clearly and effectively present information.
Excellent understanding of the roles and responsibilities of related disciplines, especially Biostatistics, Clinical Data Management, and Pharmacovigilance.
Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment with proficiency in SAS/STAT procedures.
Extensive SAS experience to develop and validate analysis datasets, tables, listings, and figures/graphs.
Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
Additional capabilities include: constructing technical programming specifications, working with relational databases, Good Clinical Practices, Good Programming Practices, 21CFR Part 11 standards, Integrated Summary Safety/Efficacy Analyses, and creating files for electronic submissions in eCTD format.
We Would Prefer For You To Have
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or a related field.
Competencies such as Accountability, Collaboration, Decision Quality, Drive for Results, Perseverance, Problem Solving, Informing, Peer Relationships, Time Management, Building Effective Teams, and Managing Through Systems.
The annual base pay range is provided in the posting. Our positions offer eligibility for incentives and benefits including retirement programs, paid time off, and health, dental, and vision coverage in accordance with applicable plans. The posting also notes that our mission is to build an inclusive environment with equal employment opportunities and accommodations available for applicants with disabilities.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x
We are unable to provide further job postings in this description. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Associate Director, Statistical Programming — Join to apply for the Associate Director, Statistical Programming role at Alexion Pharmaceuticals, Inc. The Associate Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. The candidate should have extensive experience with SAS in a Statistical Programming environment and a complete understanding of statistical programming processes, procedures, and roles. Knowledge of CDISC SDTM and ADaM standards is required to support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures and creating all files necessary to support an electronic submission in the eCTD format. The role also involves people management responsibilities, providing direct line management to the statistical programming team, identifying training needs, optimizing staff utilization, and managing the day-to-day activities of external partners to deliver program results.
You Will Be Responsible For
Lead Programmer and Manager of the statistical programming efforts, with responsibilities that may include additional duties.
Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs.
Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications.
Ensure filing of study documentation is maintained to the standard required by processes and audit requirements.
Directly support the Clinical and Statistical Programming Director in management and development of the Statistical Programming team; participate in process reviews and updates.
Create and/or review programming plans, ensure appropriate resource allocation and prioritization.
Act as primary department contact, when necessary, to ensure department standards are implemented in all studies.
Ensure adherence to company policies, SOPs, and controlled documents; align programming activities with departmental standards.
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions to address programming needs.
You Will Need To Have
7+ years of statistical programming experience in the CRO or Pharmaceutical Industry.
4+ years of project management experience in the CRO or Pharmaceutical Industry.
Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.
Strong people management and supervisory skills with experience leading cross-functional projects from concept to completion.
Strong verbal and written communication skills to clearly and effectively present information.
Excellent understanding of the roles and responsibilities of related disciplines, especially Biostatistics, Clinical Data Management, and Pharmacovigilance.
Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment with proficiency in SAS/STAT procedures.
Extensive SAS experience to develop and validate analysis datasets, tables, listings, and figures/graphs.
Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
Additional capabilities include: constructing technical programming specifications, working with relational databases, Good Clinical Practices, Good Programming Practices, 21CFR Part 11 standards, Integrated Summary Safety/Efficacy Analyses, and creating files for electronic submissions in eCTD format.
We Would Prefer For You To Have
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or a related field.
Competencies such as Accountability, Collaboration, Decision Quality, Drive for Results, Perseverance, Problem Solving, Informing, Peer Relationships, Time Management, Building Effective Teams, and Managing Through Systems.
The annual base pay range is provided in the posting. Our positions offer eligibility for incentives and benefits including retirement programs, paid time off, and health, dental, and vision coverage in accordance with applicable plans. The posting also notes that our mission is to build an inclusive environment with equal employment opportunities and accommodations available for applicants with disabilities.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x
We are unable to provide further job postings in this description. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr