Associate Director, Statistical Programming

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage 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 or follow us on LinkedIn.

Job Title

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 or follow us on LinkedIn.

Job Overview

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 to lower-level personnel 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 analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate

outputs according to the requirements.

• Help identify issues and initiates resolution of the problems.
• Act as a liaison between statistical programming, subcommittees and project teams as
• May serve as an external spokesperson for the Statistical Programming Organization.
• Create/acquire tools to improve programming efficiency or quality.
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