Senior Biostatistician

4 weeks ago

CAMBRIDGE MA, United States SRG Talent Full time

Job Title: Senior BiostatisticianLocation: Cambridge, MaWorksite: Onsite M-F; Potential HybridJob Type: Full-Time PermanentWe are searching for a full-time Senoior Biostatistician for a Global Pharmaceutical CRO located in Cambridge, Mass. This role is responsible for providing statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios.Responsibilities include, but are not limited to:Perform sample size calculations and write statistical methodology sections for inclusion in study protocolsOversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documentsDesign statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissionsDesign analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicableDevelop SAS programs to produce and/or QC statistical tables/figures/data listingsPerform mapping from raw datasets to CDISC SDTM datasetsProduce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submissionDevelop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw dataReview and/or write the statistical and results sections of clinical study reportsReview and/or assist in writing publicationsReview case report forms and data validation guidelines to ensure quality and integrity of study data collectionManage multiple projectsProvide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC reviewUnderstand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysisSupport proposal development and attend bid defense meetingsReview Request for Proposal (RFP) and Scope of Work (SOW) documentsUnderstand the SOW, budget and task assumptions, and track work completed versus budgeted tasksManage project budget and forecast resources needed for studiesWHAT YOU NEED TO HAVE: Minimum of 5 years of experience in statistical analysis of clinical trials data orMinimum of 3 years of experience in statistical analysis of clinical trials data if relevant PhD degree has been obtainedMaster's degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline required; PhD degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferredPrevious experience working for a CRO requiredExperience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methodsProficiency in SAS statistical programmingKnowledge of other statistical and data management software packages is a plusStrong written and oral communication skillsKnowledge and experience with CDISC data standards and modelsStrong project management and mentoring/leadership skills** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions. If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

  • Senior Biostatistician

    2 months ago

    Boston, MA, United States OM1 Full time

    OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics...

  • Senior Clinical Trial Biostatistician

    2 months ago

    Boston, MA, United States OM1 Full time

    OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics...

  • Senior Principal Statistician

    5 days ago

    Cambridge, Massachusetts, United States Biogen Full time

    Job DescriptionThe Senior Principal Biostatistician is responsible for leading study design and data analysis and providing the statistical expertise for company products within one or more therapeutic areas in clinical development. He/She act as independent SMT or RDPT Biostatistician, provides statistical input in the scientific discussion, participates in...

  • Senior Principal Statistician

    5 days ago

    Cambridge, Massachusetts, United States Biogen Full time

    Job DescriptionThe Senior Principal Biostatistician is responsible for leading study design and data analysis and providing the statistical expertise for company products within one or more therapeutic areas in clinical development. He/She act as independent SMT or RDPT Biostatistician, provides statistical input in the scientific discussion, participates in...

  • Senior Biostatistician

    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 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

    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

    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...

  • Senior Clinical Scientist

    5 days ago

    Cambridge, United States CYNET SYSTEMS Full time

    Job Description: Pay Range: $85.52hr - $89.52hr The primary purpose of the Clinical Scientist s position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g. Managing or contributing to the...

  • 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 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....

  • 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...

  • Statistician I

    5 days ago

    Cambridge, Massachusetts, United States Harvard University Full time

    65989BRAuto req ID:65989BRJob Code:RS0356 Statistician I Department Office Location:USA - MA - Boston Business Title:Biostatistician ISub-Unit: Appointment End Date:31-Jul-2025Salary Grade ) :056Time Status:Full-time Union:00 - Non Union, Exempt or Temporary Basic Qualifications: Master's Degree in Biostatistics, Statistics, Epidemiology, or a closely...

  • Data Scientist III

    1 month ago

    Boston, MA, United States Hebrew SeniorLife, Inc. Full time

    Overview: The Frailty Research Program at the Hebrew SeniorLife Marcus Institute for Aging Research seeks applicants for a Data Scientist III who has expertise in Medicare data programming. Our mission is to improve care of older adults with frailty by generating high-quality evidence, training future clinicians and researchers, and changing health systems...

  • Sr. Manager, Biostatistics

    4 days ago

    Cambridge, 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. The Senior Manager of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies with a focus on Modernas infectious disease vaccine programs. This position will be located in Cambridge,...

  • Sr. Manager, Biostatistics

    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. The Senior Manager of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies in Modernas clinical programs that are leveraging cutting-edge mRNA science to create transformative...

  • Sr. Manager, Biostatistics

    5 days ago

    Cambridge, Massachusetts, United States tapwage 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. The Senior Manager of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies in Moderna's clinical programs that are leveraging cutting-edge mRNA science to create transformative...

  • Sr. Manager, Biostatistics

    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. The Senior Manager of Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies with a focus on Modernas infectious disease vaccine programs. This position will be located in Cambridge,...