Lead Statistical Programmer

3 days ago


Cambridge, Massachusetts, United States Global Channel Management Full time

About the Position: As a Lead Statistical Programmer - Clinical Studies at Global Channel Management, you will be responsible for leading clinical studies and integrated analyses, providing guidance and training to lower-level personnel.

Key Responsibilities:

  • Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration.
  • Contribute to statistical analysis plans; provide expertise in the analysis of clinical trials 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.

Requirements:

  • Minimum 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience.
  • FDA submission experience is highly desirable.
  • Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat.
  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experienced in managing multiple projects.
  • Solid knowledge of SAS Programming language, Software Development Life Cycle, and CDISC standards (SDTM & ADaM).
  • Solid knowledge of other software such as SpotFire, R Shiny, etc., is a plus.
  • BS/MS in Statistics, Math, or Scientific Discipline.

Benefits: In addition to a competitive salary, we offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.



  • Cambridge, Massachusetts, United States Alnylam Full time

    About the Role: As a Statistical Programming Director at Alnylam, you will lead statistical programming teams and activities for complex clinical development compounds. This includes worldwide regulatory submissions, representing Statistical Programming as part of Clinical Trial Working Groups (CTWG), Clinical Development Teams, and/or Clinical Filing teams....


  • Cambridge, Massachusetts, United States Global Channel Management Full time

    About the job: Senior Statistical LeadThe ideal candidate will have 10 years of experience in Pharmaceutical/Biotech programming, with a focus on macro/tools development. This role requires strong SAS programming and statistical background skills, including expertise in SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat. Additionally, experience with FDA...


  • Cambridge, Massachusetts, United States Global Channel Management Full time

    About the Job: We are seeking an experienced Principal Biometrics Programmer to join our team at Global Channel Management. The ideal candidate will have a strong background in biometrics programming and a passion for delivering high-quality results.Key Responsibilities:Create CDISC SDTM and ADaM files, SAS export files, Define.xml, and Reviewer's Guide for...


  • Cambridge, Massachusetts, United States Nuvalent Inc. Full time

    About Nuvalent Inc.With a strong focus on chemistry, Nuvalent Inc. is working to create targeted medicines designed with the goal of addressing the needs of patients with cancer. As an exciting early-stage company, we bring together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and...


  • Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryWe are seeking a highly skilled Statistical Programming Director to lead our statistical programming activities across multiple studies and related oversight activities ensuring quality and timeliness.About the RoleThis is a leadership position that requires strong general knowledge of technical and programming methods, combined with applied...


  • Cambridge, Massachusetts, United States Intellia Therapeutics Full time

    Imagine a workplace where innovation and determination drive you to excel and succeed together. At Intellia Therapeutics, we're pushing boundaries in genome editing treatments for severe diseases. As our Director Biostatistics, you'll be part of this mission, leveraging your expertise to positively transform lives.About the RoleProvide leadership and...


  • Cambridge, Massachusetts, United States Intellia Therapeutics Full time

    About the RoleAs a Director Biostatistics and Analytics Lead, you will be part of our Clinical Development team at Intellia Therapeutics. We are looking for a seasoned professional with expertise in statistics, programming languages (SAS, R, or Python), and experience working in the Pharmaceutical/Biotechnology industry. This is a great opportunity to take...


  • Cambridge, Massachusetts, United States National Bureau of Economic Research Full time

    Salary: $80,000 - $110,000 per annum, depending on experience. Location: Cambridge, MA. Required Skills and Qualifications: Strong analytical background, knowledge of statistical software (STATA, SAS, or R), ability to communicate clearly and write documentation. A Bachelor's degree in data science, statistics, economics, or related quantitative field is...


  • Cambridge, Massachusetts, United States Maxis Clinical Sciences Full time

    About the RoleAs a Senior Biostatistician at Maxis Clinical Sciences, you will be leading the statistical development strategy for our therapeutic antibodies. This is an exciting opportunity to leverage your expertise in drug development and biostatistics to drive innovation in clinical trials.Key ResponsibilitiesDevelop and implement statistical strategies...


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time

    What We OfferWe offer a competitive salary of $145,000 - $170,000 per year, commensurate with experience. In addition to a comprehensive compensation package, we provide medical, dental, and vision insurance for eligible employees and their families, 401(k) plan with a 4% Company match, and eligibility to accrue up to 23 paid time off days per full year...


  • Cambridge, Massachusetts, United States Hobson Prior Full time

    Role OverviewHobson Prior is seeking an experienced Associate Director of Biostatistics to lead the statistical aspects of early-stage clinical trials. This senior role involves designing and analysing trials, preparing data for regulatory submissions, and collaborating with internal and external teams.This position offers a unique opportunity for career...


  • Cambridge, Massachusetts, United States Capital One Full time

    Company OverviewData is at the heart of everything we do. As a leader in data-driven decision-making, we have disrupted the credit card industry by individually personalizing every credit card offer using advanced statistical modeling and relational databases. Fast-forward a few years, and this innovation has skyrocketed us to a Fortune 200 company.We are...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    About the RoleAs a Clinical Data Management Lead, you will be responsible for leading and contributing to data management activities in support of Alnylam studies across all stages of clinical drug development.ResponsibilitiesLead data management activities as a program-level lead data manager in support of Alnylam clinical studies Lead database build...


  • Cambridge, Massachusetts, United States Third Rock Ventures Full time

    Role Overview:We are seeking a highly experienced Senior Manager/Associate Director, Quality Control to lead our QC activities for antibody and fusion protein products across our pipeline.About the Job:In this role, you will develop strategies and execute QC activities for all pipeline programs. This includes in-process/release/stability testing,...


  • Cambridge, Massachusetts, United States Alnylam Full time

    Overview:Alnylam Pharmaceuticals, a leading biopharmaceutical company, seeks an experienced Clinical Data Management Lead to join our team. The successful candidate will have a strong background in clinical data management and be responsible for leading data management activities in support of Alnylam studies across all stages of clinical drug...


  • Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Transforming Healthcare with AnalyticsWe are seeking a highly skilled Data Science expert to join our team at BioSpace, Inc. in Cambridge, MA. As a leading pharmaceutical company, we are committed to driving innovation and improving patient outcomes through data-driven insights.About the Role:As a Data Science expert, you will work closely with our...


  • Cambridge, Massachusetts, United States Third Rock Ventures Full time

    A key role within Third Rock Ventures' stealth new company is available for a Biotech Formulations Lead. This position will be responsible for developing and delivering phase-appropriate materials for animal and clinical studies.About the JobCollaborate with discovery, non-clinical, clinical, and CMC teams to establish core operations of the team.Develop...


  • Cambridge, Massachusetts, United States EverQuote Full time

    EverQuote, a leading online marketplace for insurance shopping in the United States, is seeking an experienced Data-Driven Analytics Lead to join its team.About the RoleWe are looking for a highly skilled and motivated individual who can drive business growth through data analysis and strategic decision-making.This role offers a salary of approximately...


  • Cambridge, Massachusetts, United States Harvard University Full time

    Job Summary: We are seeking a highly skilled Strategic Research Lead to join our team at the Harvard Graduate School of Education.About the Role: The successful candidate will lead and contribute to research and assessment projects that address strategic questions, enhance offerings and operations, and fulfill reporting responsibilities at HGSE. This is a...


  • Cambridge, Massachusetts, United States Telnet Inc Full time

    Telnet Inc is seeking a highly skilled Medical Device Manufacturing Engineering Lead to join our team in Cambridge, MA. As a key member of our engineering team, you will play a crucial role in developing and implementing efficient manufacturing processes for medical devices.Salary: $120,000 - $160,000 per year.About the JobWe are looking for an experienced...