Associate Director, Biostatistics
About The Position
Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidates 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.
Requirements
- PhD degree in Biostatistics, Statistics, Mathematics, Biology or related field of study
- seven (7) years of experience in the job offered or related occupation in which the required experience was gained.
- Must have demonstrated experience with: SAS programming
- Bayesian analysis
- dose-response modeling
- superiority and futility interim analysis
- clinical development through Phase 3
- ICH GCP
- R programming language and statistical software (EAST)
- CDISC (SDTM, ADaM and CDASH)
- representing sponsors in meetings with interaction with US FDA and international regulatory authorities
- designing and conducting adaptive trials.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
