Senior Biostatistics Lead, Clinical Trials (Hybrid)

Alnylam Pharmaceuticals, Inc.; Maidenhead; Hybride; GBP 120 000 - 160 000; Plein temps

Résumé du poste

Alnylam Pharmaceuticals in Maidenhead is seeking an Associate Director of Biostatistics to lead statistical activities for clinical trials, including trial design input, protocol statistics sections, SAP preparation, and interpretation of trial analyses.

The role is hybrid with two onsite days weekly and requires a PhD with extensive biostatistics experience or an MS with substantial relevant experience, plus SAS and CDISC expertise and regulatory collaboration.

Qualifications

• Ph.D. in Biostatistics or Statistics or equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience.
• Excellent written and oral communication and presentation skills.
• Experience programming in SAS.
• Interest in and basic understanding of biology and biological processes, including RNAi.

Responsabilités

• Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
• Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs.
• Provides statistical guidance on conduct of ongoing trials.
• Collaborates with Statistical Programmers on summary and analysis of trial data.
• Writes ADS and ad hoc analysis specifications.
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
• Contributes to scientific articles, summarizing data collected in Alnylam trials.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
• Consults with Research & Preclinical colleagues on statistical questions in their work.
• Manages CRO statistical and programming support.

Connaissances

Written and oral communication

Statistical thinking and data analysis

Formation

PhD in Biostatistics or Statistics

MS in Biostatistics or Statistics

Outils

SAS

R

EAST

CDISC (SDTM/ADaM/CDASH)

Description du poste

Alnylam Pharmaceuticals in Maidenhead is seeking an Associate Director of Biostatistics to lead statistical activities for clinical trials, including trial design input, protocol statistics sections, SAP preparation, and interpretation of trial analyses.

The role is hybrid with two onsite days weekly and requires a PhD with extensive biostatistics experience or an MS with substantial relevant experience, plus SAS and CDISC expertise and regulatory collaboration.