Job Description: As a Biostatistician, you will lead projects with mentorship from senior staff to deliver the project statistician tasks/responsibilities. You will be involved with designing and analyzing medical devices and biological clinical trials. Successful candidates will work on regulatory submissions and directly contribute to Company success by increasing the strength of study designs, interpretability of results, and facilitating collaboration with internal and external teams.

Responsibilities:

• Apply knowledge of basic and complex statistical design, analysis, and programming techniques utilized in clinical research.
• Develop and reviews statistical analysis plans based on study-specific documents and sound statistical methodology.
• Develop, maintain, and produces statistical programs and specifications used in creating analysis datasets, tables, listings, and figures.
• Interact with the sponsor, internal, and external team members.
• Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation. Provide guidance for database structures for analysis.
• Provide randomization schemes and appropriate documentation.
• Programs/validate statistical tables with an emphasis on efficacy endpoints. Provide proper documentation and oversees the work of others who assist in programming/validating.
• Understand and comply with all company policies and standard operating procedures.
• Maintain a professional working relationship with sponsors, collaborating associates, and vendor personnel.

Requirements:

• Ph.D. with 1-3 years’ experience, or a master’s degree with 3-5 years’ experience in Biostatistics, Statistics, or a similar field.
• 3+ years CRO experience.
• Lead Experience.
• Knowledge of FDA and ICH Guidelines required.
• Knowledge of statistical design, analysis, and programming techniques utilized in clinical research required.
• Good SAS® programming skills and understanding of database structures.
• Ability to work on multiple projects at once.
• Sense of ownership and pride in your performance and its impact on the company's success
• QC experience is a plus
• Good time-management skills
• Excellent interpersonal, written, and oral communication skills.

No 3rd party agencies.