Spyre Therapeutics - Senior Director, Biostatistics
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. Working knowledge of Bayesian methodology and causal inference is preferred. • 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. • Experience in people management is preferred.
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.
Benefits
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships. • The expected salary range offer for this role is $275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
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