Senior Manager, Statistical Programming

Company: Sumitomo Pharma
Location: Providence
Posted on: September 12, 2023

Job Description:

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com (https://myovant-my.sharepoint.com/personal/gina_cromwell_myovant_com/Documents/Documents/072023%20Transition%20documents/JDs/Sumitomo-pharma.com) ]
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Statistical Programming . This is a remote based role that will require some travel for meetings. The Sr. Manager, Statistical Programming will provide statistical programming support to clinical trials for regulatory submissions and various post-marketing analyses for publications and posters, support the Biostatistics function in statistical analysis and develop and maintain the infrastructure for project files of SAS datasets and SAS programs in compliance with the technical conformance guidance from different authorities.
Job Duties and Responsibilities
Manage project deliverables (multiple studies), ensuring that timelines are met and expected quality is attained.
Train and/or mentor junior level programmers.
Liaise with Clinical, Data Management and Biostatistics for database and dataset specifications, timelines, and quality requirements, and other study requirements as necessary.
Create and validate SDTM and ADaM datasets and associated submission deliverables in compliance with published industry standards and project/study specific requirements.
Create and validate TFL output in compliance with study specific requirements.
Support regulatory submissions via the delivery of all required data structures and documentation.
Interface with and manage external data partners and vendors; review specifications.
Create and maintain supporting documentation; review supporting documentation created by other programmers.
Contribute to departmental process improvements; SOPs and WIs.
Maintain professional currency through:- Demonstrable expertise in SAS analysis and reporting programming.- Demonstrable expertise with CDISC CDASH, SDTM, ADaM, DEFINE-XML, and/or controlled terminology.- Implementation of standard clinical data solutions best practices from CRF design through data analysis and reporting.- Attendance and presentation at appropriate scientific meetings and conferences.
Perform other duties as assigned.
Key Core Competencies
Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively.
Exercise good judgment and make decision that is appropriate for the organization.
Results-driven, take initiative and ownership to accomplish work.
Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
Strive for continuous improvement and embrace innovative ideas in daily work.
Regularly required to sit for long periods of time.
Education and Experience
B.S. or equivalent in computer science, mathematics, or life science.
A minimum of 8 years of relevant clinical research programming experience, specifically in the pharmaceutical industry.
Demonstrable experience/expertise in analysis and reporting of phase I-IV clinical trial.
Demonstrable experience/expertise using SAS/Base and SAS/Stat.
Demonstrable experience/expertise using CDISC standards: CDASH, SDTM, ADaM, DEFINE-XML, Controlled Terminology.
Demonstrable proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Ability to work on a computer for extended periods of time.
Regularly required to use hands to operate computer and other office equipment.
Close vision required for computer usage.
The base salary range for this role is $124,200 to $163,000. 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 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.
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) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All 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, gender identity or expression; 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.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com (https://protect-us.mimecast.com/s/ENgOCyPOPLtrAy4kHMAry5?domain=sumitomo-pharma.com/) ]
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

Keywords: Sumitomo Pharma, Providence , Senior Manager, Statistical Programming, Executive , Providence, Rhode Island