Associate Director, Statistical Programming jobs in United States
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CSL · 17 hours ago

Associate Director, Statistical Programming

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. The Associate Director, Statistical Programming provides leadership and expertise in developing and maintaining statistical programming capabilities to meet regulatory obligations, ensuring high quality and timely delivery of projects.

BiotechnologyHealth CareHealth DiagnosticsMedical
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Comp. & Benefits

Responsibilities

Working with the Director, Programming to assess upcoming activities and resulting resource needs and ensure high quality, timely, delivery of assigned projects. Ensure realistic project planning
Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis
Plans and leads the design and implementation of complex specifications and programs for applications designed to analyze and report complex clinical trial data in CDISC format
Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other ad-hoc requests
Mentors programmers allocated to assigned projects and provides feedback to managers of aligned team members as needed
As a project or program leader ensures compliance with programming process and strategy to facilitate accurate and timely programming
Test and implement state of the art programming methods and tools to the organization and drive automation of delivery, including AI
Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality

Qualification

SAS SoftwareStatistical ProgrammingCDISC StandardsSAS MacrosClinical ProgrammingSolutions Oriented MindsetInterpersonal SkillsCommunication SkillsLeadership

Required

BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
At least 10 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software
Comprehensive understanding of clinical programming and/or statistical programming processes and standards
Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros
Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
Experience in working in cross-functional, multicultural and international clinical trial teams
Coding in SAS, including SAS macro language
Interest and/or experience in expanding beyond SAS as the primary programming delivery tool
Experience in and/or passion for automatization of routine programming tasks
Broad knowledge of clinical development and processes
Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
Ability to collaboratively work and provide leadership in matrix environment
A solutions oriented mindset
Fluency in technical requirements for CDISC compatible datasets and DDT files

Preferred

Other degrees and certifications considered if commensurate with related programming experience
Presentations of programming techniques at professional conferences is a plus

Company

CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.

Funding

Current Stage
Public Company
Total Funding
$111M
2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO

Leadership Team

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Jeffrey Ball
Chief Sustainability Officer
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Joy Linton
Strategic Advisor
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Company data provided by crunchbase