Alexion Pharmaceuticals, Inc. · 2 months ago
Associate Director, Statistical Programming
Boston - Seaport Boulevard
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
7+ years expAlexion Pharmaceuticals, Inc. is seeking an Associate Director of Statistical Programming to oversee statistical programming activities for clinical studies. The role includes managing programming infrastructure, ensuring compliance with SOPs, and providing leadership to the statistical programming team while collaborating with various functions to support programming needs.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Serve as the Lead Programmer and Manager of the statistical programming efforts. This may include additional responsibilities including, but not limited to:
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
Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit
Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Responsibilities will include, but are not limited to:
Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary
Create and/or review programming plans, and ensure appropriate resource allocation and prioritization
Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies
Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support
Qualification
Required
7+ years statistical programming experience in the CRO or Pharmaceutical Industry
4+ years 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 skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion
Strong verbal and written communication skills - ability to clearly and effectively present information
An excellent understanding of the roles and responsibilities of all related disciplines, in particular 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 a demonstrated mastery of SAS/STAT procedures
Extensive experience and proven skills in the use of SAS within a Statistical Programming environment 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
Advanced experience with: Constructing technical programming specifications
Relational Databases
Good Clinical Practices
Good Programming Practices
21CFR Part 11 Standards
Integrated Summary Safety/Efficacy Analyses
Creating all files necessary to support an electronic submission in the eCTD format
Preferred
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area
Competencies: Accountability, Collaboration, Decision Quality, Drive for Results, Perseverance, Problem Solving, Informing, Peer Relationships, Time Management, Building Effective Teams, Managing Through Systems
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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2025-12-20
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