[ref. n1284816] Wilmington - Principal Biostatistician - Biopharma
AL Solutions Wilmington Full-time
George Higginson is currently searching for an experienced Principal Biostatistician. He is partnering with a commercial biopharmaceutical company working heavily across the Oncology, Inflammation and Autoimmunity space.
Main Responsibilities:
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Provide statistical input to study protocols.
- Write statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Assist in writing relevant sections of the clinical study report.
- Participate and contribute to authoring of Clinical Development Plan.
- Participate in pre-IND and NDA activities.
- Participate in the development and enforcement of SOPs and guidelines.
- Other responsibilities as required.
Requirements:
- Ph.D. degree in statistics required.
- 3-5 years of experience in pharmaceutical/biotechnology/CRO industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
- History working independently in project management and decision making.
- Experienced across Phases I-III.
- Ability to use SAS to perform efficacy analyses, validating data derivations when necessary.
- Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
- Knowledge of multivariate analyses and Biomarker analyses is a plus.
How To Apply:
AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.
George Higginson
Senior Associate
AL Solutions
george@alsolutions.co.uk
FMD K&LFort Washington (PA), 34 mi from Wilmington (DE)
The Principal Biostatistician serves a lead role on project and interacts with team members in designing and analyzing clinical trials. Key responsibilities and skills include, but are not limited to:
• Protocol development including study design...
PfizerCollegeville (PA), 32 mi from Wilmington (DE)
Advanced degree in statistics, biostatistics, or related field.
+ A minimum of 4 years' experience in the clinical trial setting (preferably in oncology of Pharma).
+ Relevant clinical trial, real-world data, and business experience providing...
NavitsPartnersPhiladelphia, 17 mi from Wilmington (DE)
communication skills.
• Translate statistical information effectively for various audiences.
Education:
• Minimum: Master’s degree in Health Economics, Biostatistics, Health Services Research, Public Health, Epidemiology, Pharmacy Administration, or related...