Senior Statistical Programmer - Lead, Clinical Submissions
Biogen, Inc.
Biogen operates a hybrid role in the Cambridge/Durham area seeking a Senior Analyst, Statistical Programming to lead programming activities and oversee vendor work, delivering submission-ready outputs with minimal supervision. You will manage study timelines, resource needs, and collaborate with Biostatistics to implement data standards, develop ADaM datasets, and ensure compliance with CDISC and regulatory guidelines across trials. #J-18808-Ljbffr Biogen, Inc.
- ...of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of... ...standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be... ...analysis Creating and reviewing submission documents and eCRTs...SeniorRemote workFlexible hours
- Alnylam US, Inc. in Cambridge, MA seeks a Principal Statistical Programmer to develop SAS programs for clinical trial reporting. You will create TLFs, LS, and... ...knowledge, and collaboration with CROs to support FDA submissions. Hybrid in-office/remote work is offered in the...SeniorWork at officeRemote work
$110k - $165k
...Opportunity OverviewRhythm is seeking a Statistical Programmer to join our Biostatistics and... ...hands-on support across clinical studies, regulatory submissions, and cross-functional development... ...decision-making.Serve as a study lead programmer or programming representative...SuggestedWork at office- ...SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers... ...SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and... ...SDTM and ADaM and FDA electronic data submission requirements. Familiarity with FDA and...Suggested
$80.6k - $145k
...Sr Statistical Programmer (NA Only) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner... ..., anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development...SeniorContract workFlexible hours- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...Senior
- ...Statistical Programmer (SAS Programmer)Integrated Resources, Inc is a premier staffing firm recognized... ...areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and... ...compliance with SOPs and other documents.Leading capability assessments of Biometrics...Work experience placement
- ...project delivery, including clinical trial reports and other regulatory submission deliverables. Create statistical analysis outputs to be used... ...to and coordinate and lead a statistical programming team... ...into, and mentor statistical programmers to provide input into...Remote work
- ...9 Job Summary: The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas.... ...clinical development and regulatory submissions. The position involves hands-...Contract workShift work
- Vertex Pharmaceuticals seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials. This on-site or hybrid role requires hands-on experience with risk-based audit strategies, CAPA, and inspection readiness within sponsor...Senior
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our... ...Massachusetts. This role involves collaborating on clinical documents and overseeing contract... ...experience, familiarity with regulatory submissions, and excellent project management skills...SeniorContract work
- Jobtailor is seeking a seasoned biostatistician to serve as the statistical lead for one or more clinical programs in the U.S. You will provide technical leadership on trial design, conduct, and analysis, and collaborate closely with cross-functional teams to shape development...Senior
- ...searching for a Sr. Director of Biostatistics to serve as the statistical lead for various clinical programs. You will provide technical leadership and... ...successful clinical study designs and regulatory submissions. The ideal candidate holds a PhD in statistics with extensive...Senior
$150k - $210k
...combine continuous physiological data with clinical research and expert knowledge to... ...for sleep, recovery, and exercise.As a Senior Machine Learning Engineer on our Core Algorithms... ...applying advanced mathematical and statistical techniques.This role is based in the WHOOP...SeniorFull timeWork at officeRelocation- ...Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program. You will develop key clinical... ...functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorContract work
$153.6k - $207.8k
...team is seeking an experienced Clinical ProServe Cloud Architect (PCA... ...customers, including senior technology and business leaders... ...responsible for creating and leading solution designs to address customer... ...data operations, regulatory submissions, and study lifecycle...SeniorFlexible hours- Datalign Advisory, LLC. in Cambridge is seeking a Senior Software Engineer with deep AI/ML expertise to join a high-impact engineering team. In this hands-on technical leadership role, you will architect and build systems that power financial advisory products. The ideal...Senior
$82.3k - $220k
A leading independent research company based in Cambridge, MA is looking for a Senior Systems Engineer. The role involves working with multidisciplinary teams to develop secure solutions that resist cyber and supply chain threats. The candidate should have a Bachelor's...Senior$235k - $285k
...making our One Team culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of a culture that welcomes... ...CMC development, from preclinical through clinical stages with regulatory submission experience (IND/CTA, BLA/MAA). Excellent oral and...SeniorTemporary workLocal area- Maxwell Bond is seeking a Senior Robotics Software Engineer to lead the development of a new mobile application and supporting cloud platform. You will work across mobile, web and cloud technologies, making key architectural decisions and writing production-quality software...Senior
- ...Senior Life Sciences Knowledge Engineer Company: Norstella... ...Norstella? Norstella unites market-leading companies that all have a... ...Responsibilities: Translate complex clinical, regulatory, and life... ...Experience working with and statistically analysing large and complex data...SeniorFull timeTemporary workWork at officeLocal areaRemote workFlexible hoursShift work
- Software Engineer, Levels up to Principal and Lead, Golang, NATS, Microservices, Boston, MA Hybrid, 150k midpoint**Note: I also represent... ...of data. Refreshing the basic components of the ecosystem (statistics, analytics, accounting, billing, notification service,...Permanent employmentLive inRemote work
- ...something groundbreaking as we transition from clinical development to our commercial launch. Lumicell is seeking a Senior Software Engineer to work in a dynamic,... ...release documentation to support regulatory submissions and audits Collaborate closely with systems...SeniorFull timeCasual workImmediate startMonday to FridayAfternoon shift3 days per week
$127.5k - $195.5k
...the way. Take responsibility for the quality of the code produced by you and the team. Contribute to a SaaS platform used in clinical trial workflows, ensuring reliability, data integrity, and compliance with industry standards. Collaborate with clinical, QA,...SeniorFull time- Regeneron is seeking a Manager-level Programmer to provide timely support for the study team on all programming matters, leading programming deliverables from data processing to regulatory submission. This onsite role in Cambridge involves overseeing code, logs, and outputs...Senior
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions...Senior
$149.58k - $166.2k
...deliver exceptional service to seller and buyer clients.As a Senior Software Engineer on the Staff AI Enablement Team, you will be... ...strictly protected.Maintain Code Quality & Governance: Review code submissions, establish robust testing frameworks for LLM outputs, and...SeniorMinimum wageImmediate startFlexible hours$108k - $209k
...experienced, creative, and talented Principal / Senior Software Engineer. The ideal candidate... ...product development, with the ability to lead projects and communicate effectively... ...from any source other than candidates. The submission of unsolicited resumes by recruitment or...Senior$108k - $150.67k
...least one to two days per week)Position: Senior Software Engineer, Full StackAbout the RoleThe... ...with well-scoped tasks guided by our lead software engineer, and progressively take... ...on the technical side. The genomic and clinical domain is complex and constantly changing...SeniorFull timeWork at officeLocal areaFlexible hours2 days per week1 day per week- We are hiring a Senior Software Engineer with deep expertise in AI/ML engineering and data... ....For over 50 years, Verisk has been the leading data analytics and technology partner to... ....S. in Computer Science, Mathematics, Statistics, or a related quantitative field; M.S....SeniorWork at officeFlexible hours
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