Senior Manager, Programming

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 or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Programming. Senior Manager, Programming will serve as a programing liaison between the SMPA team and the parent company SMP's team and will provide programming support to clinical trials of non-oncology indications

Job Duties and Responsibilities

• Serve as a programming point of contact between SMPA and SMP. Facilitate communication and collaboration between SMP programming and SMPA programming, biostatistics, data management, clinical research, clinical operations, medical writing and CROs.

• Lead and manage the contactor programmers and provide programming support to clinical trials for regulatory submissions and publications, and ad hoc or post hoc analyses. Generate SDTM/ADaM datasets, listings, tables and figures, as well as supporting documentation (i.e. define.xml) for clinical trials.

• Function as lead (or co-lead together with SMP) programmer on single or multi-protocol projects and participate in project team meetings. Assume protocol level responsibilities in programming. Review protocol and SAP, write/review SDTM/ADaM specifications, etc. Interact with biostatisticians, data managers, clinical operations personnel and project manager to ensure the timeline and quality of SDTM/ADaM data and reporting.

• Independently validate SDTM/ADaM datasets and outputs from CROs or other programmers. Prepare validation documentation.

• Develop and maintain SAS programming infrastructure, macros and standards. Adhere to the company's and departmental SOPs, Working Instructions and Standards.

Key Core Competencies

• Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO.

• Experience creating/reviewing/validating CDISC SDTM and ADaM datasets.

• Experience with creation and review of CDISC-formatted electronic submission deliverables is desirable.

• Extensive experience in creating/reviewing/validating tables, figures, listings, and documentation necessary to support electronic submissions and publications.

• Demonstrated NDA, sNDA submissions and ISS/ISE experience.

• Working familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC SDTM and ADaM).

• Strong communication skills both oral and written.

• Strong organizational and time management skills and the ability to handle multiple assignments effectively and deal with ad hoc requests.

• Ability to proactively plan so as to minimize potential re-work, as well as effectively and efficiently solve problems.

Education and Experience

• Bachelor’s or Master’s degree with 5-7 years programming experience in the pharmaceutical industry or equivalent experience. Education in statistics is highly desirable.

The base salary range for this role is $155,360 to $194,200.    Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements