Clinical SAS Programmer

3 weeks ago

Cambridge, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget.
  • Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences.
  • Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer's guide, annotated CRFs) conforms to SOPs and to regulatory specifications.
  • Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.
  • Ensure timely delivery of all statistical deliverables for each study assigned.
  • Collaborate with study statistician and study team members to come up with timelines for statistical programming deliverables and other related action items.
  • Follow departmental SOPs and processes for operational excellence.
  • Lead statistical programming activities for regulatory submissions following CDISC standards.
  • Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan.
  • Take ownership for the completion of SDTM and ADAM specifications for assigned studies.
Requirements:
  • Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
  • Thorough knowledge of SDTM/ADaM specifications and programming
  • Strong SAS programming and graphic programming skills
  • ble to guide the successful completion of major programs and projects.
  • Strong analytical and communication skills
  • Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies.
  • Broad knowledge of medical/biological terminology in relevant therapeutic areas.
  • Experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings.
  • Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses.
  • Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus.
  • Experience in management of CROs with respect to statistical programming.

  • Senior SAS Programmer

    1 month ago

    Cambridge, United States IntePros Full time

    RESPONSIBILITIES:Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.Offer technical support and expert advice to internal and external sponsors.Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.Implement programming and project standards in accordance...

  • Senior SAS Programmer

    1 month ago

    Cambridge, United States IntePros Full time

    RESPONSIBILITIES:Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.Offer technical support and expert advice to internal and external sponsors.Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.Implement programming and project standards in accordance...

  • Senior SAS Programmer

    1 month ago

    Cambridge, United States IntePros Full time

    RESPONSIBILITIES:Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.Offer technical support and expert advice to internal and external sponsors.Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.Implement programming and project standards in accordance...

  • Senior Statistical Programmer

    6 days ago

    Cambridge, United States Prometrika LLC Full time

    Job DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...

  • Senior Statistical Programmer

    4 weeks ago

    Cambridge, United States Prometrika LLC Full time

    Job DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...

  • Senior Statistical Programmer

    4 days ago

    Cambridge, United States Prometrika Full time

    PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market....

  • Principal Statistical Programmer

    4 weeks ago

    Cambridge, United States Prometrika LLC Full time

    Job DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...

  • Principal Statistical Programmer

    1 week ago

    Cambridge, United States Beacon Therapeutics (USA) Inc Full time

    Job DescriptionJob DescriptionExciting opportunity for an experienced Clinical Statistical Programmer to join our team at Beacon Therapeutics (USA) Inc. as a Full Time Principal Statistical Programmer. In this fully remote position, you will have the chance to showcase your expertise in statistical programming while contributing to cutting-edge biotech...

  • Sr Statistical Programmer

    2 months ago

    Cambridge, United States Connect Life Sciences Full time

    Acts as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.Assumes leadership responsibility as a contributing member of a multidisciplinary...

  • Senior Manager, Statistical Programming

    5 days ago

    Cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical...

  • Senior Manager, Statistical Programming

    4 days ago

    Cambridge, United States Bicycle Therapeutics Full time

    Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical...

  • Senior Manager, Statistical Programming

    4 days ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on...

  • Manager, Statistical Programming

    5 days ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    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 leveraging cutting-edge mRNA...

  • Senior Clinical Research Director, I&I

    4 days ago

    Cambridge, United States Professional Diversity Network Full time

    The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs. The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks. The role of the Senior CRD is to: Act as a...

  • Manager, Statistical Programming

    6 days ago

    Cambridge, United States Moderna Full time

    **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-edge...

  • Senior Developer, Data Visualizations and Application Development

    6 days ago

    Cambridge, United States Biogen Full time

    Job Description About This Role The Sr Developer, Data Visualizations and Application Development should be an experienced R or R Shiny programmer with a passion for developing applications and visualizations for clinical trial data. This role will build tools that allow users to better interact with clinical trial data or that make our clinical...

  • Associate Director, Biostatistics

    4 weeks ago

    Cambridge, United States Pfizer Full time

    WHY PATIENTS NEED YOU This position will provide statistical support for projects in the Inflammation and Immunology disease area in Global Product Development. You will collaborate and work closely with project or study teams and provide statistical expertise in designing clinical trials, developing protocols, writing statistical analysis plans, performing...

  • Senior Developer, Data Visualizations and Application Development

    1 week ago

    Cambridge, United States Biogen Full time

    About This Role The Sr Developer, Data Visualizations and Application Development should be an experienced R or R Shiny programmer with a passion for developing applications and visualizations for clinical trial data. This role will build tools that Application, Development, Developer, Data, Programmer, Senior

  • Associate Director, Statistical Programming

    5 days ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    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 Associate Director of Statistical Programming will be responsible for statistical programming deliverables across Modernas development programs that are leveraging...

  • Manager, Statistical Programming

    5 days ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    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 leveraging cutting-edge mRNA...