Cambridge, MA Posted: 5/7/2020
Serves as Lead Biostatistician for one or more individual clinical studies within a clinical program or across multiple clinical programs. Will provide statistical input to clinical studies, including input into the study design through statistical analysis and reporting. Will also be involved in the statistical deliverables for a submission. Is responsible for providing appropriate statistical oversight of studies, where the lead biostatistician role is outsourced to an external CRO or other vendor. Also responsible for exploratory statistical analysis for lifecycle management activities of development compounds. Will collaborate effectively with cross-functional colleagues and other experienced biostatisticians, especially for all aspects related to the clinical development plan and regulatory submission strategy.
- Works very closely with the other biostatisticians and the program-level biostatistician and the lead biostatistician at the assigned CRO or other vendor.
- Participates in the protocol summary development. Gives input into the study design, efficacy and safety parameters and the planned statistical analyses. Performs the sample size calculations. Participates in protocol development if this is not delegated to an external partner biostatistician. Reviews and approves the protocol prepared by the external partner biostatistician.
- Responds to the request for the randomization schedule. Interacts appropriately with the IXRS vendor if this is not delegated to an external partner biostatistician.
- Reviews data management related documents. Evaluates the quality of the database if this is not delegated to an external partner biostatistician.
- Authors the Statistical Analysis Plan (SAP) or reviews and approves the SAP if prepared by an external partner biostatistician.
- Coordinates with other internal or external biostatisticians and statistical programmers to prepare the statistical analyses. Communicates and coordinates all statistical activities with external partner biostatisticians.
- Participates in data review/evaluation meetings and other study-related meetings and activities.
- Reviews the clinical study report and provides input on interpretation of results by attending the Results Interpretation Meeting (RIM).
- Ensures implementation of the global and program and GSS standards.
- Attends study team meetings and collaborates with the team to meet timelines.
- Guides and supports internal and external biostatisticians assigned to support the clinical studies. Acts as a resource for junior biostatisticians on the team.
- Understands the regulatory requirements related to design and analysis of studies.
- Assists the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.
- Contributes and reviews abstracts, posters, presentations and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents.
- Senior Biostatistician with sufficient experience may serve as a biostatistician lead for a program of studies, as agreed to by their line manager.
- Adheres to the company SOPs and working procedures.
- Other duties may be assigned.
- Ph.D. or Master’s degree in biostatistics or a related discipline.
- 5+ years in biostatistics within the biotechnology and/or pharmaceutical industry (including CROs) with a proven successful track record in pharmaceutical development.
- Experience in all phases of clinical studies, with particular experience in Phase II – III.
- Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from EU, US and Japanese health authorities, and of the submission process in each.
- Good knowledge of statistical methodology.
- Experience with sample size software.
- Good knowledge in clinical study related SAS and/or R programming
Already have an account? Log in here