Lead Biostatistician embedded in a global biotech team focused on autoimmune disease, designing and implementing statistical methodologies for complex clinical trials and research projects.
Compensation
The salary range estimated for this position based in Massachusetts is $135,000.00–$175,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Responsibilities
Design and implement statistical methodologies for complex clinical trials and research projects
Collaborate with cross-functional teams
Provide strategic guidance on study design and analysis
Contribute to innovative research and advance possibilities for people living with autoimmune disease
Requirements
Advanced Degree in Biostatistics, Statistics, or a closely related quantitative field
Bachelor's Degree in Biostatistics, Statistics, or a closely related quantitative field
Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy, including the CDISC-based sponsor standards library.
Responsibilities
Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy.
Own and evolve the Pierre Fabre Sponsor Standards Library built on top of CDISC standards.
Establish standards governance processes, lifecycle management, version control and change management practices.
Lead the development, maintenance and governance of standards covering eCRF libraries, SDTM, ADaM, edit checks, controlled terminology and study metadata.
Ensure Pierre Fabre standards remain aligned with evolving regulatory expectations and industry best practices.
Requirements
Master's Degree or PhD in life sciences, data management, statistics, programming or a related field
Provide hands‑on statistical programming support for clinical studies, developing and validating analysis datasets, tables, listings, figures, and graphs for regulatory submissions and internal presentations.
Compensation
Bill Rate is *** On Site or Remote Provide hands‐on statistical programming support for clinical studies, including development and validation of analysis datasets and statistical outputs, in accordance with regulatory and company standards.
Responsibilities
Develop complex analysis datasets, specifications, and summary outputs
Create, modify, and maintain SAS programs
Perform independent program review and validation
Support ad hoc and planned analyses
Partner with Clinical Data Management and Biostatistics
Requirements
Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field
Master’s degree (or equivalent) in a related field
Nice to have: R
Nice to have: Python
Nice to have: Experience with regulatory submissions
Lead statistical strategy and execution for Denali’s clinical development programs, ensuring rigorous analysis and regulatory compliance.
Compensation
Salary Range: $155,000.00 to $202,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
Responsibilities
Lead development of key clinical study deliverables
Ensure statistical integrity and accuracy of analysis and reporting
Conduct exploratory analyses, sample size estimation, and modeling/simulation
Interpret and present data to project teams and senior management
Oversee biostatistics vendors and CROs
Requirements
PhD in Statistics, Biostatistics, or related discipline
Master’s degree in related discipline with equivalent experience
Lead and oversee all clinical data management activities across multiple therapeutic areas, ensuring compliance with regulatory standards and driving process improvements.
Compensation
Salary Range: $212,000.00 to $276,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.
Responsibilities
Provide leadership and oversight for the execution of clinical data management activities
Manage a team of Managers and Clinical Data Associates
Direct and guide team through DM lifecycle
Drive CDM organizational strategy and lead implementation of change initiatives
Collaborate with cross-functional teams to meet project deliverables
Requirements
BA/BS or higher in math, science, or health-related field
The anticipated base pay range for this position is : $140,000.00 - $241,500.00
Responsibilities
Providing strategic technical leadership and expertise in roles that directly support Clinical and Statistical Programming Therapeutic Area
Strategic partnering with leads, user community and departmental/external stakeholders to identify innovation, automation and continuous improvement opportunities
Leading complex departmental innovation and process improvement projects
Coaching and training clinical and/or statistical programmers to support continuous enhancement of technical capabilities
Senior executive leadership role to shape and drive enterprise-aligned AI strategy for Immunology R&D and translate that strategy into an executable, value-focused portfolio of AI capabilities, data products, and AI solutions.
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
The anticipated base pay range for this position is : $204,000.00 - $351,900.00
Responsibilities
Define and maintain the Immunology AI strategy
Lead strategic portfolio planning for Immunology AI
Create an integrated execution model across Immunology and enabling functions
Partner with Immunology scientific and development leaders
Provide technical leadership and informed challenges on AI solution design
Requirements
Advanced degree (PhD, MD, PharmD, MS, or equivalent experience) in computer science, AI/ML, engineering, biomedical sciences, computational biology, applied mathematics, data science, or a related scientific or technical discipline