Marlborough, Massachusetts, United States · Hybrid
$168k–$210k/yr
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 dis…
Skills: SAS Programming, CDISC SDTM, CDISC ADaM, Pinnacle 21, Statistical Analysis
Marlborough, Massachusetts, United States · On-site
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Marlborough, Massachusetts, United States · On-site
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Description Senior Scientific Document Specialist Location: Marlborough, MA Department: Lab Operations About the Opportunity Meadowhawk Biolabs is seeking an enthusiastic and highly motivated Senior Scientific Document S…
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Marlborough, Massachusetts, United States · On-site
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Marlborough, Massachusetts, United States · On-site
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Marlborough, Massachusetts, United States · Hybrid
$150k–$187k/yr
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 dis…
Skills: Trade Compliance, Logistics Management, HTS Classification, Customs Regulations, GxP Compliance
Marlborough, Massachusetts, United States · On-site
$38/hr–$78/hr
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Marlborough, Massachusetts, United States · On-site
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$20/hr–$22/hr
Lab Assistant I - Marlborough, MA, Tuesday to Saturday, 11:00 p.m. to 7:00 a.m. Pre-Analytical Assistant I is responsible for general support functions within the Technical Operations Department. Pay range: $20.10 - $22.…
Skills: Data Entry, Medical Terminology, Production Environment, General Support Functions
Marlborough, Massachusetts, United States · On-site
Become the social worker you aimed to be and dedicate yourself to meaningful work with the patients you treat. Join MTC Care as a social worker and make a true difference in people’s lives each and every day. This is a u…
Skills: Psychotherapy, Treatment Planning, Clinical Documentation, Crisis Intervention, Patient Assessment
Marlborough, Massachusetts, United States · On-site
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The Regional Director of Commercial Excellence is a leader in the business driving the execution of the Commercial operating plan as a partner to the Regional Vice President, Commercial. A successful candidate will drive…
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We are seeking a Lead Product Development Engineer to drive the design, development, verification, validation, and commercialization of innovative medical devices from concept through launch and sustaining transfer. In t…
Skills: Product Development, Design Controls, Risk Management, Verification and Validation, Design Transfer
Marlborough, Massachusetts, United States · On-site
Occupational Therapist Children’s Mental Health Services Mobile position in communities surrounding Marlborough, MA FEE FOR SERVICE $50 PER HOUR 10 HOURS PER WEEK - MINIMUM OF 2 DAYS PER WEEK ` The Edinburg Center is see…
Skills: Sensory Integration, Fine Motor Skills, Gross Motor Skills, Social Skills, Self-care Skills
Marlborough, Massachusetts, United States · On-site
Clinician (Mental Health Specialty Flex) Mobile position in the Central communities of Massachusetts (Worcester) Full-Time salaried $65,000 Who You Are: An individual who has earned a master’s degree and is license-eligi…
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Marlborough, Massachusetts, United States · On-site
BCBA (MENTAL HEALTH SPECIALTY FLEX) Mobile Position in Central Massachusetts ( Worcester) The Edinburg Center is looking for a BCBA for our Mental Health Specialty Flex Team - this is not your ordinary BCBA role! Full-ti…
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Marlborough, Massachusetts, United States · On-site
$47/hr–$78/hr
Are you a current UMass Memorial Health caregiver? Apply now through Workday. Exemption Status: Non-Exempt Hiring Range: $47.05 - $78.34 Please note that the final offer may vary within this range based on a candidate’s …
Skills: Patient Assessment, Nursing Process, Care Planning, Discharge Planning, Clinical Supervision
Marlborough, Massachusetts, United States · On-site
$47/hr–$78/hr
Are you a current UMass Memorial Health caregiver? Apply now through Workday. Exemption Status: Non-Exempt Hiring Range: $47.05 - $78.34 Please note that the final offer may vary within this range based on a candidate’s …
Skills: Patient Assessment, Nursing Process, Care Planning, Discharge Planning, Clinical Supervision
Marlborough, Massachusetts, United States · On-site
$17/hr–$27/hr
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Skills: Customer Service, Communication Skills, Mathematical Reasoning, Problem Resolution, Attention and Focus
Marlborough, Massachusetts, United States · On-site
$34/hr–$37/hr
Medical Laboratory Scientist I - Marlborough, MA (Night Shift) Monday - Friday 11:00PM - 7:00AM, with rotational weekends Department: Auto Chemistry Are you intrigued by the science of the human body? Curious about state…
Skills: Clinical Laboratory Testing, High Complexity Testing, Auto Chemistry, Laboratory Instrumentation, Diagnostic Services
Marlborough, Massachusetts, United States • Hybrid
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Lead the planning and execution of statistical programming activities to generate analysis datasets, tables, and figures for safety and efficacy analyses. Manage team members and collaborate with biostatisticians to implement statistical analysis plans and ensure regulatory compliance for electronic submissions.
Requires a minimum of 8 years of pharmaceutical programming experience, including 2 years of people management and mandatory FDA submission experience. A degree in Statistics, Math, or a scientific discipline is required, along with expert-level SAS and CDISC standards knowledge.
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.
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 other team members 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
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 - $210,000.00Base 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.
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.
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.
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 reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS. SMPA was formed through the consolidation of Sumitomo Pharma’s U.S. affiliate companies including Sunovion Pharmaceuticals, Inc., Sumitomo Pharma America Holdings, Inc., Sumitomo Pharma Oncology, Inc., Sumitovant Biopharma, Inc., Myovant Sciences, Inc., Urovant Sciences, Inc. and Enzyvant Therapeutics, Inc. SMPA is a Sumitomo Pharma company. Community Guidelines: https://www.us.sumitomo-pharma.com/social-media/index.html
Offices: 84 Waterford Drive, Marlborough, Massachusetts 01752, US
There are currently 229 open healthcare positions in Marlborough, MA listed on Clera. New openings are added daily as companies post roles.
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