Associate Director, Biostatistics
About The Position
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. 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.
Requirements
- PhD degree in Statistics, Biostatistics, Mathematics or a related field of study and five (5) years of experience in the job offered or related occupation in which the required experience was gained.
- In lieu of a PhD degree in Statistics, Biostatistics, Mathematics or a related field of study and five (5) years of experience, the employer will also accept a Master’s degree in Statistics, Biostatistics, Mathematics or a related field of study and eight (8) years of experience in the job offered or related occupation in which the required experience was gained.
- Demonstrated experience with: Clinical development through Phase 3 (NDA Submission).
- Representing sponsors in meetings with US FDA and international regulatory authorities.
- Drug development for rare genetic diseases.
- SAS programming.
- Designing and conducting adaptive trials.
- ICH GCP.
- R programming language and other statistical software, including EAST.
- CDISC, including SDTM, ADaM, CDASH.
Responsibilities
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
