Associate Director, Statistical 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 Duties and Responsibilities

• Lead on clinical studies and manage/provide training to team members when needed.

• Contribute and implement statistical analysis plans; provide additional expertise in the

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• 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

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• Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer’s

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• 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

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• Help identify issues and initiates resolution of the problems.

• Act as a liaison between statistical programming, subcommittees and project teams as

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• May serve as an external spokesperson for the Statistical Programming Organization.

• Create/acquire tools to improve programming efficiency or quality.

• Establish monitoring of data transfers for ongoing trials to identify study conduct or data

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• Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

• Perform other duties as assigned.

Key Core Competencies

• Support End-to-End Statistical Programming using SAS

• Ability to generate documents / files required for regulatory filing. Ex. Reviewers’ Guides, Define.XML, Annotated CRFs etc.

• Executing Pinnacle 21 Checks

• Knowledge about CDISC and Regulatory Guidelines

• Demonstrate coaching skill to mentor Statistical Programmers

• Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc.

Education and Experience

• Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience.

• Ability to use professional concepts to achieve objectives in innovative and efficient ways.

• FDA submission experience is a must.

• Solid knowledge of CDISC standard (SDTM & ADaM).

• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.

• Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.

• BS/MS or equivalent in Statistics, Math or Scientific Discipline

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 flexible 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 unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.