Spyre Therapeutics
Senior Director, Biostatistics
US- Remote · Director
Sponsorship not specifiedDetected 19 days ago
StatisticsProject ManagementClinical TrialsPharmacovigilanceSASResearchExperimental DesignLeadershipCommunicationBiostatisticsEpidemiology
About the role
- Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
- Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned.
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
- Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings
- collaborate closely with data manager to ensure high-quality data
- Build and develop efficient biostatistical processes and standards, when appropriate
- Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data
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.
- 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
Compensation
- The expected salary range offer for this role is $ 275,000 to $290,000.
Benefits
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
Equal opportunity
- As an equal opportunity employer, Spyre is committed to a diverse workforce.
Apply directly at Spyre Therapeutics →Create a free account for alerts like thisView Spyre Therapeutics immigration profile
This listing is sourced directly from Spyre Therapeutics's careers page and normalized into a canonical job model.