Spyre Therapeutics

👥 1-50💰 $180,000,000 Post-IPO Equity over 1 year agoBiotechnology Therapeutics📈 Public Company

Spyre Therapeutics is a biotechnology company focused on developing innovative antibody therapies aimed at transforming the treatment landscape for inflammatory bowel disease (IBD).

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Jobs at this company:

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🔥 Director, Statistical Programming

Posted 2 days ago

💸 220000.0 - 239000.0 USD per year

🔍 Biotechnology

🔧 Requirements

MS Degree in Biostatistics, Statistics, or a related field with 8-10+ years of experience in statistical programming within the pharmaceutical, biotech, or CRO industry.
Extensive experience in the life sciences sector with a strong understanding of drug development processes.
Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and their application in clinical studies across all phases.
Strong proficiency in SAS programming, including macro development, ODS graphics, and experience with SAS/STAT procedures
Thorough understanding of regulatory requirements for statistical programming in submissions to FDA, EMA, PMDA, and other health authorities.
Experience in preparing and reviewing key documents for regulatory submissions (e.g., SAP, SDTM/ADaM spec, Define files, Reviewer's Guide).
Proficiency in electronic data capture (EDC) systems and clinical data management processes, relational database structures, and data workflow.
Experience with data visualization tools (e.g., R Shiny, Spotfire, Tableau) is a plus.
Familiarity with cloud-based computing environments and big data technologies.
Excellent project management skills and ability to handle multiple projects simultaneously.
Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.
Excellent interpersonal communication skills, along with organizational skills.
Excellent communication and interpersonal skills.
Ability to work collaboratively in a multidisciplinary team environment.

💡 Responsibilities

Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.
Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on study-specific data structures and endpoints.
Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (e.g., DSUR), and publications.
Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.
Assist managing resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.
Serve as the statistical programming representative in cross-functional study teams and external collaborations.
Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.
Stay current with evolving trends in I&I clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.
Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.
All other duties as assigned.

Posted 2 days ago

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🔥 Clinical Trial Manager, Clinical Operations

Posted 7 days ago

💸 135000.0 - 155000.0 USD per year

🔍 Biotechnology

🔧 Requirements

B.A./B.S. in life sciences or equivalent
A minimum of 6 years of clinical research experience within the pharmaceutical or biotechnology industry, with at least 2+ years managing early phase clinical trials; managing global clinical trials a plus
Inflammation and/or Immunology experience is strongly preferred
Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out
Informed consent development and EU CTR experience
Ability to lead cross functional study teams in a matrix organization
Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures
Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions.

💡 Responsibilities

Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion.
Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements.
Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR.
Lead the identification, evaluation, selection, and oversight of clinical trial sites.
Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
Responsible for implementation and oversight of Trial Master File for inspection readiness.
Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members.
Provide study updates and reports, inclusive of study risks and issues.
Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings.
Responsible for ongoing study data reviews and data cleaning activities.
Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, sample tracking, interim monitoring and close out activities.
Manage trial-level quality risk management.
Oversee study supplies management.
Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes.
Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
Other duties as assigned.

Posted 7 days ago

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🔥 Senior Director, Biostatistics

Posted about 1 month ago

📍 US

💸 275000.0 - 313000.0 USD per year

🔍 Biotech

🔧 Requirements

PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.
Strong knowledge of statistical methodologies and their application in clinical trials and health research.
Experience with regulatory submissions and interactions with regulatory agencies.
Proficiency in statistical software (e.g., SAS, R) and data management systems.
Experience with CDSIC including SDTM, ADaM, CDASH
Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.
Excellent communication and interpersonal skills, along with organizational skills.
Ability to work collaboratively in a multidisciplinary team environment.

💡 Responsibilities

Lead the biometrics team including statistician, data manager, and statistical programmer at a program level
Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies
Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies
Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings
Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data
Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines
Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities
Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses
Build and develop efficient biostatistical processes and standards
Other duties as assigned

LeadershipProject ManagementPeople ManagementSAS EGCommunication SkillsAnalytical SkillsData management

Posted about 1 month ago

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