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
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
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
needed.
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 quality issues.
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 8 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 standards (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 R Shinny etc. is a plus.
BS/MS or equivalent in Statistics, Math or Scientific Discipline
The base salary range for this role is
$168,000.00 - $210,000.00
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, in accordance with applicable law.
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 is involved. 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.
Travel Requirements:
Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.
Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
Sumitomo Pharma America (SMPA) is an
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.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
