Sumitomo Pharma Co. , Ltd.
pharmaceutical
StatisticalProgrammingAssociateDirector
Neural analysis suggests this role is
optimal for Director candidates.
“Statistical Programming Associate Director at Sumitomo Pharma Co. , Ltd.. Skills: SAS, Statistical programming, CDISC standards. Plan statistical programming activities. Design SAS programs”
Industry & Context.
Exercise appropriate judgment; Identify issues; Initiates resolution of the problems
Ability to use a personal computer for extended periods of time, Travel domestically and internationally as needed
What They're Looking For.
Must Have
SAS programming, Statistical background, SAS Base, SAS/Macros, SAS/Graph, SAS/Stat, FDA submission experience, CDISC standards (SDTM & ADaM)
Nice to Have
R Shinny
What You'll Do.
Plan statistical programming activities
Validate SAS programs
Document SAS programs
Generate analysis datasets
Generate data listings
Generate summary tables
Generate statistical graphs
Analyze clinical data
Evaluate clinical data
Modify computer programs
Generate ad-hoc listings
Generate ad-hoc tables
Generate ad-hoc figures
Champion best practices
Enhance Programming value
Lead clinical studies
Implement statistical analysis
Review Data Management Plan
Review Data Transfer Plan
Review Data Validation Plan
Review Edit Check Specifications
Create analysis specifications
Create CDISC SDTM files
Create SAS export files
Create Reviewer’s Guide
Perform Data analysis
Perform statistical analysis
Generate safety tables
Generate efficacy tables
Generate safety listings
Generate efficacy listings
Generate safety graphs
Generate efficacy graphs
Interact with Statisticians
Interact with clinical teams
Perform ad hoc analysis
Initiate problem resolution
Improve programming efficiency
Improve programming quality
Monitor data transfers
Identify study conduct issues
Identify data quality issues
Perform integrated summaries
Perform Clinical Study Reports
How You'll Work.
Team & Collaboration
Collaborate with cross-functional teams; Collaborate with Biostatisticians; Collaborate with Clinicians; Collaborate with Data Managers; Liaison between statistical programming, subcommittees and project teams
Communication Scope
Excellent written communication skills; Excellent oral communication skills
Process & Methodology
Manage team members, Lead on clinical studies
Full Job Description
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website [_https://www.us.sumitomo-pharma.com_](https://www.us.sumitomo-pharma.com) or follow us on LinkedIn. Responsible for planning and tracking statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses. Design, develop, evaluate and modify computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures. Contribute to and champion best practices to enhance the value and contribution of Programming across other therapeutic areas. Enforce the appropriate standards in the department and provide training. **Job Duties and Responsibilities** * Lead on clinical studies and manage/provide training other team members when needed. * Contribute and implement statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection. * Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. * Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP) * Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer’s Guide for Electronic Submission. * Perform Data analysi
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