- R+D/ Global Development Support
- Greater Pennsylvania area
- A Biopharmaceutical company is looking to hire a Manager, Biostatistics position. This position will be acting as a project-level and study-level statistician. This role is accountable for statistical aspects of study design, for organizing the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work together with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and clinical data analysis and will supervise the work of statistics and programming external vendors.
The Manager, Biostatistics position will have responsibilities that include:
- Present timely and scientifically sound statistical expertise to clinical development projects.
- Partake in division and cross-functional meetings to optimize clinical study designs, endpoints, and analysis approaches.
- Work Together with representatives of project teams to establish project timelines and to develop and implement protocols
- Work closely with data management, clinical operations, clinical data analysis, and other biostatisticians to develop and validate study-specific data capture systems
- Create statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation
- Supervise CROs regarding statistical issues and activities to ensure timely delivery of analysis results
- Offer guidelines and standards to CROs to ensure quality of deliverables. Partake in CRO selection process
- Attend regulatory meetings to support and defend clinical programs.
- Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data
- Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.
The ideal candidate will have the following skill set:
- MS, MPH, or PhD in statistics, mathematics, or related field, with 4+ years (MS) or 2+ years (PhD) experience
- Advanced understanding of clinical trial design and analysis
- Competent in US drug development regulatory requirements as they relate to statistics
- Involvement in contributing to NDAs or BLAs
- Knowledge with pharamcokinetic/pharmacodynamic data, a plus
- Proficient in using SAS; knowledge of other statistical applications and programming languages a plus
- Experience using CDISC SDTM and ADaM models and standards
- Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) a plus
- Excellent in both oral and written communications