Senior Director, Biostatistics

Spyre Therapeutics

. Provide leadership and strategic input for assigned clinical development programs .

Posted 10/5/2026full-timeUnited StatesSenior💰 $295,000 - $314,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics and statistical methodologies, with a strong focus on clinical trial design, regulatory submissions, and collaboration within multidisciplinary teams. Proficient in statistical software and data management systems, ensuring high-quality data and successful project outcomes.

Highest-signal resume keywords

PhD Degree In Biostatistics10-12 Years Of Experience In BiostatisticsStrong Knowledge Of Statistical MethodologiesProficiency In SAS And RExperience With CDISC Including SDTM, ADaM, And CDASH

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical MethodologiesClinical Trial DesignSample Size CalculationStatistical Analysis PlansBayesian MethodologyRegulatory SubmissionsData Management SystemsStatistical AnalysesCRF DevelopmentResults Interpretation

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsCollaborative TeamworkProblem-Solving

Tools & Technologies

SASRCDISCSDTMADaMCDASH

Industry Keywords

Pharmaceutical IndustryBiotech IndustryCRO IndustryHealth ResearchClinical Development

About the role

Key responsibilities & impact

Provide leadership and strategic input for assigned clinical development programs
Lead the biometrics team, including statistician, data manager, and statistical programmer, at a program level
Support clinical trial design, protocol development, sample size calculation, CRF, results interpretation, clinical study reports, and regulatory agency questions
Research advanced and innovative statistical methods to increase the probability of clinical study success
Author and develop statistical analysis plans and specifications for derived variables, statistical tables, figures, and listings
Guide study teams on statistical activities and collaborate with data managers to ensure high-quality data
Participate in cross-functional study activities with Clinical Development, Clinical Operations, Clinical Data Management, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, staff, and vendors
Establish CRO/vendor oversight procedures and ensure accurate, timely deliverables
Contribute to global Health Authority submissions and participate in meetings or teleconferences
Coordinate statistical analyses for IB, DSUR updates, periodic safety updates, and ad hoc analyses
Manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files
Perform other duties as assigned

Requirements

What you’ll need

PhD Degree in Biostatistics, Statistics, or a related field
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
Working knowledge of Bayesian methodology is preferred
Experience with regulatory submissions and interactions with regulatory agencies
Proficiency in statistical software, such as SAS and R, and data management systems
Experience with CDISC including SDTM, ADaM, and CDASH
Successful track record of working independently in a matrixed organization and providing solutions to emerging problems
Excellent communication, interpersonal, and organizational skills
Ability to work collaboratively in a multidisciplinary team environment

Benefits

Comp & perks

Market competitive compensation and benefits package
Performance bonus
Equity grant opportunities
Health, welfare & retirement benefits
Unlimited PTO
Two, one-week company-wide shutdowns each
Professional development opportunities
Remote working environment with frequent in-person meetings
Opportunity to work in a fast-paced, dynamic environment and help shape the culture of a young company