Title: Associate Director, Biostatistics
Company: Biotechnology Company
Location: Waltham, MA
Type: Permanent Role
Notes: No Corp to Corp
- Perform, advise, and review protocol development, sample size calculation, protocol and CRF review
- Ensures the accurate programming of SAS clinical data extracts and data displays.
- Provide statistical input into and perform review of SAPs, table shells, programming and table specifications, TLFS, and statistical sections for integrated reports, statistical sections of CSRs, database design, validation checks and critical data, and data review
- Work with data management personnel in the preparation of datasets that are of high quality and in usable format
- Advise on regulatory issues including integrated summaries of efficacy and safety, and represent the sponsor in meetings with regulatory authorities
- Provide statistical support for translational research, biomarker strategy, and discovery.
- Performs statistical analyses, including hypothesis testing and modeling.
- Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met by internal and external clients.
- Conducts exploratory analyses from study datasets to develop additional hypotheses for future studies.
- Effectively coordinate statistical endeavors with outside organizations, CROs and consultants
- Participate in establishment and development of department SOPs
- Ph.D. degree in biostatistics or statistics with a minimum of 4 years of experience or a Master's degree in biostatistics or relevant field with 7+ years of clinical research and drug development experience. This will include supporting the design of clinical trials and analysis/reporting of clinical trials data in the pharmaceutical industry with experience in oncology.
- Advanced knowledge of statistical methods that apply to oncology focused clinical trials
- Prior NDA/BLA and IND experience is a must
- Broad and thorough understanding of statistical principles, particularly with respect to statistical methodology with observational/real world data; able to practice and implement them
- Ability to clearly communicate statistical concepts and results to diverse team members
- In-depth knowledge of applicable clinical research regulatory requirements (i.e. GCP and ICH guidelines)
- Strong working knowledge of SAS programming
- Experience working withtranslational research teams
- Ability to effectively manage and lead multiple tasks and projects
- Ability to establish and maintain effective working relationships with coworkers
- Strong verbal and written communication skills
- Ability to communicate statistical information to non-scientists, willingness to educate internal team
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