Director Biostatistics

POSITION SUMMARY

This position serves as a key member of Clinical Development team, supporting multiple programs in oncology/immunology across all stages of development. The position is responsible for providing study/compound level statistical expertise and leadership by assuming responsibility for innovative study designs, statistical methodology, data analysis, interpretation, and regulatory interactions.

POSITIONS RESPONSIBILITIES

• Works with clinical trials physician(s), to direct and support the planning and implementation of clinical programs to meet corporate and clinical research goals.
• Serves as a statistical lead for one or more oncology/immunology clinical trials, facilitates the coordination of all statistical activities for these clinical trials.
• Provides scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
• Participates in the design and review of clinical protocols and case report forms for clinical trials including the preparation of statistical considerations sections, sample size calculations, interim looks, randomization, and study design recommendations. Produces statistical section of clinical protocol.
• Creates and implements statistical analysis plans and specification documents
• Contributes to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical/regulatory submission documents.
• Communicates study results including internal communication as well as manuscripts, or oral presentations in scientific meetings
• Provides guidance to programmers and analysts on statistical procedures
• Identifies and works with existing external statistical experts for consultation
• Develops and implements innovative statistical methodology

TECHNICAL QUALIFICATIONS

• PhD. or M.S. in biostatistics, statistics, mathematics, or related field.
• At least 7 years of experience in pharma, biotech, or a related sector.
• Comprehensive understanding of the drug development process from Phase I to Phase III.
• Solid understanding of all functional area responsibilities associated with clinical development process
• Advanced knowledge of clinical study designs and statistical methodologies for analysis
• Ability to effectively collaborate with internal/external colleagues and stakeholders
• Comfortable working in a multi-national, matrix environment
• Leadership/influencing skills, excellent skills in oral and written communication.
• Manages conflicts/issues with internal and external partners and customers
• Able to anticipate, recognize and resolve problems/issues that may impact timelines and deliverables
• Proficiency in statistical programming languages/software such as SAS, R etc.
• Well-versed in the clinical and regulatory requirements for global submissions