Senior Statistical Programming Lead for CDISC & NDA
Alnylam
The Associate Director, Statistical Programming at Alnylam Pharmaceuticals, Inc. in Cambridge, MA, leads statistical programming activities for clinical trials, ensuring the quality and timely delivery of SAS-based deliverables in accordance with ICH guidelines and regulatory requirements. The role requires SAS expertise and strong leadership of programming teams, with experience in CDISC standards (SDTM/ADaM) and Define-XML; knowledge of R is strongly preferred for data visualization and #J-18808-Ljbffr Alnylam
- ...Pharmaceuticals seeks an Associate Director, Statistical Programming to lead programming activities for clinical trials and NDA submissions. You will ensure SAS programs are... ...regulatory requirements. Role requires SAS expertise, CDISC ADaM/SDTM experience, and leadership of...Senior
$136.4k - $253.2k
...Science is recognized as a leading hub for top industry talent,... ...exploratory analyses, and align statistical programming practices across both early-... ...Program Lead serves as a senior leader within the Analytical... ...regulatory data standards (e.g., CDISC, ADaM, SDTM)You have a...SuggestedFull timeLocal area$215k - $270k
...technical leadership for the statistical programming function, driving the... ...Clinical Development, and lead and mentor a team of... ...are met. Serve as the senior technical expert on CDISC standards (SDTM, ADaM), programming... ...submissions (e.g., NDA/BLA). Substantial experience...SeniorFull timeWork at officeImmediate startRemote workFlexible hours2 days per week3 days per week$150.5k - $245.5k
A leading biotechnology firm is seeking a Senior Manager to oversee project programming support for clinical studies. The candidate will lead programming efforts, develop programming... ...leadership and a strong understanding of statistical programming. Comprehensive benefits are...Senior$136.96k - $205.44k
...Summary:The Principal Statistical Programmer works with management... ...in the role of project lead Statistical Programmer.... ...activities, often at Senior Management... ...GRAPHIntermediate knowledge of CDISC StandardsIntermediate... ...educational assistance programs including student loan...SuggestedFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week- Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager Statistical Programming to support project teams in Cambridge, MA. This role involves leading programming efforts for clinical study data, ensuring compliance with regulatory standards and mentoring junior...Senior
$215k - $270k
...Therapeutics seeks a Director or Senior Director of Statistical Programming to provide strategic and... ...technical expert on CDISC standards, programming methodologies... ...Partner with Biometrics Lead to define long-term vision... ...regulatory submissions (NDA/BLA) Substantial CRO and...Senior$242k - $313k
...delivering category-leading precision... ...Summary: The Senior Director, Biostatistics... ...providing strategic statistical leadership for the... ...methodology for assigned programs, leading the... ...for INDs, NDA/BLA submissions, and... ...analysis datasets (CDISC SDTM/ADaM), and integrated...SeniorLocal areaFlexible hours2 days per week$119.7k - $222.3k
...and motivated PK Sciences representative to lead the development and use of artificial... ...biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses... ...years of experience to be considered for Senior Principal Scientist.Extensive and in-depth...SeniorFull time$150.5k - $245.5k
Position Summary A Senior Manager Statistical Programming provides timely support to the project team on all programming matters according to the project... ...and guidelines. The incumbent is responsible for leading the programming aspect of the project, both internally...Senior- ...Capital One is seeking a Full-stack Engineer 4 to lead a portfolio of microservices and full stack systems, delivering cloud-based solutions for risk and compliance needs. You will collaborate with product managers and guide a team of engineers in a fast-paced, iterative...Senior
$155k - $225k
...committed to establishing the leading, fully integrated... ...of base editing programs. Beam is a values-driven... ...Overview:Beam is seeking a Senior Manager/Associate Director... ...to support the statistical design, execution, analysis... ...submissions, including NDA/BLA/MAA activities, is...SeniorFull time- ...for obtaining results Provide statistical input for protocol development,... ...summaries for New Drug Application (NDA) submissions Design analysis... ...plan and table shells, and CDISC ADaM standards if applicable Develop SAS programs to produce and/or QC statistical...Work experience placement
- 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
$90k - $135k
...Overview Rhythm is seeking a Senior Statistical Programmer to join our Biostatistics and Statistical Programming team. This role will provide... ...and Duties Lead or support statistical programming... ...documentation in compliance with CDISC and global regulatory requirements...SeniorFull timeWork at office- MBX Biosciences, Inc. is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data. This role ensures quality and accuracy of deliverables, oversees vendor performance, and drives process...
- ...50% Remote Responsibilities: Lead and manage clinical data management... ...form design, and edit check programming. Strong knowledge of clinical... ...guidelines, GCP, GCDMP, and CDISC standards. Demonstrated... ...Office Suite and familiarity with statistical software (e.g., SAS, R) is a...Work at officeRemote work
$132.23k - $176.31k
...today. The Role Black Lotus Labs has an opening for a Senior Lead Security Engineer that will leverage Lumen’s unique visibility... ...thinking and ability to quickly pick up new methods, tools and programming languages. User-level experience in a Unix-based...SeniorFull timeTemporary workWork experience placementWork at officeRemote work$212k - $333.19k
...patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of... ...role, you will lead a top-priority program, building cross-functional teams capable... ..., including major submissions (NDA/BLA/MAA)For the project(s) of responsibility...SeniorMinimum wageLocal areaRemote workWorldwide- ...biostatistics, data management, and regulatory submissions. This role focuses on statistical design, analysis, and CDISC-compliant reporting for diverse clinical trials. The candidate will lead SAS programming efforts, collaborate with protocol design teams, and guide junior...Senior
$144.8k - $217.2k
...Boston, Massachusetts.SummaryThe Senior Manager, Clinical Data... ...serves as the Data Management lead for assigned clinical trials... ...requirementsKnowledge of CDISC standards, including CDASH and... ...stakeholders, including Biostatistics, Statistical Programming, Pharmacovigilance, Clinical...Senior$150k
...change. BCG delivers solutions through leading-edge management consulting along with technology... ...of people and technology. As a Senior AI Tech Architect, you will collaborate... ...analytics architecture (e.g. Data Lake).Programming paradigms and approaches (e.g. object-oriented...SeniorContract workWork at officeLocal area$139k - $186k
About This RoleThe lead of digital marketing measurement and data science is responsible... ...BIO, and creative agencies to develop statistical and machine learning models. The scope... ...extraction and manipulationProficiency in programming languages such as Python or R for data...Full timeTemporary workLocal area$263k - $292k
...Overview:Prime Medicine is a leading biotechnology company... ...therapeutic programs organized around our core... ...seeking an experienced Senior Director, Biometrics to... ...will provide statistical expertise across Prime... ...lockData standards (e.g., CDISC/SDTM/ADaM expectations...SeniorFull timeTemporary workInterim role- ...enterprise environments. The senior principal strategic research... ...external sources and surveillance programs. This position will work... ...work and use highly specialized statistical techniques and cutting edge... ...Functions:Participate in and/or lead efforts in the strategic...SeniorFull timeTemporary workFor contractorsFor subcontractorLocal areaImmediate start
$195k - $255k
...and collaborate with leading academics in our areas... ...consulting firm).About the Senior Biostatistician... ...including contributing statistical expertise to a major regulatory... ...Develop tools, programming standards, and best practices... ...SAPs, TLFs, and CDISC-compliant SDTM and...SeniorWork experience placementWork at officeLocal areaVisa sponsorship$210k - $300k
...Rhythm is seeking a Senior Director, Biostatistics... ...important clinical development programs. This individual will serve as the lead statistician for... ...the opportunity to shape statistical strategy for programs that... ...preferred. ~ Familiarity with CDISC requirements, including...SeniorInterim roleWork at officeFlexible hoursShift work$138k - $184.5k
...presently looking to fill a Senior Scientist position... ...parenteral drug product programs to support Biogen’s... ...drug product development.Lead development of sterile... ...submissions including IND, IMPD, NDA and responses to health... ...is a plus.Knowledge of statistical software, design or...SeniorFull timeTemporary workLocal area$80k - $150k
Senior Clinical Data Manager, Clinical Data Management, R&D, Orion... ...as the data management lead for oncology clinical trials... ...Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory... ...datasets. Ensure compliance with CDISC standards (CDASH and SDTM),...Senior$109.9k - $179.3k
...Responsibilities Lead or support programming and quality control of analysis datasets, tables, listings, and graphs Create and maintain... ...documents Provide programming support for presentations and statistical ad hoc requests Coordinate activities and communicate...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Statistical Programming Lead for CDISC & NDA. Be the first to apply!
- senior safety specialist Cambridge, MA
- senior mulesoft developer Cambridge, MA
- senior business manager Cambridge, MA
- senior linux systems engineer Cambridge, MA
- senior mainframe developer Cambridge, MA
- senior cloud security engineer Cambridge, MA
- senior level Cambridge, MA
- senior project manager Cambridge, MA
- senior network engineer remote Cambridge, MA
- senior manager product development Cambridge, MA




