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Amylyx Pharmaceuticals
Cambridge, MA, United States
Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases incl
Job Source: Amylyx PharmaceuticalsAmylyx Pharmaceuticals Inc
Cambridge, MA, United States
Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases incl
Job Source: Amylyx Pharmaceuticals IncSobi
Waltham, MA, United States
Job Description We are looking for someone to lead and develop the North American team as well as providing mentoring, support and professional development to individual members of the Statistical Programming Team. In addition, work as Statistical Programmer providing communication skills and expertise in the preparation of regulatory, clinical, a
Job Source: SobiBioSpace, Inc.
Cambridge, MA, United States
Job Details The Role: This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliverables across Modernas development programs that are leveragi
Job Source: BioSpace, Inc.Moderna
Cambridge, MA, United States
The Role: This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliverables across Moderna's development programs that are leveraging cutting-e
Job Source: ModernaBioNTech IMFS
Cambridge, MA, United States
Press Tab to Move to Skip to Content Link Open for hire at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube . Become a member of the BioNTech Family! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges
Job Source: BioNTech IMFSKalVista Pharmaceuticals, Inc.
Cambridge, MA, United States
About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand
Job Source: KalVista Pharmaceuticals, Inc.Center for Biostatistics in AIDS Research (CBAR)
BOSTON
The Center for Biostatistics in AIDS Research (CBAR), an organization within the Harvard Chan School of Public Health, is actively recruiting an Associate Director of Statistical Programming to lead statistical programming efforts for a busy research ; The individual will be responsible for collabor...
Job Source: Center for Biostatistics in AIDS Research (CBAR)Cambridge, MA, United States
THE OPPORTUNITY
Reporting to the Head of Statistical Programming, you will be responsible for providing hands-on programming support and technical guidance on clinical trials and regulatory submissions. In this role you will lead design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. You will participate in departmental and cross functional technology development and process improvement initiatives.
RESPONSIBILITIES
Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets including datasets specifications for datasets programming.
Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, fit-for-purpose analysis datasets, and TFLs.
Create and review eCTD documents to support regulatory submission package.
Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
Provide programming support for ad hoc analyses and data listing review.
REQUIREMENTS
MS in Statistics, Computer Science, or a related field with at least 6 years of SAS programming experience in the pharmaceutical or biotech industry. (BS in Statistics, Computer Science ore related field with at least 8 years’ experience in pharma or biotech also considered).
Proficient in SAS programming.
In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
Working knowledge of R strongly preferred.
Experience in leading statistical programming to early and late phase clinical trials, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format and regulatory submissions (NDA, MAA).
Experience with FDA and ICH regulations and guidelines.
Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
Excellent written and verbal communication skills and organizational and documentation skills.
Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
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Email Alert for Lead, Statistical Programming jobs in Cambridge, MA, United States
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