Job Description:

This full-time, exempt-level position reports to the Senior Director, Biostatistics and Data Management. The individual filling this position will be a key member of the development team for assigned studies. The successful candidate will understand the implications and logistics of the study protocol requirements and will ensure that appropriate processes and procedures are put in place for timely, high quality deliverables. This includes responsibility for the preparation of the statistical analysis plan and the execution of all the supporting activities for its successful implementation, including validation of underlying databases.

• Interact with clinical research personnel, data management and medical writers in planning, design, conducting, evaluation, interpretation and presentation of study results and reports.
• Proactively identifies issues and proposes solutions in support of activities that are specific to anti-infectives, such as patient evaluability and pathogen determinations.
• Assist in the selection of appropriate statistical methods for design and analysis of studies and projects.
• Review and advise on statistical study methodologies and statistical results; advise medical team members.
• Contribute to preparation of responses on statistical issues raised by regulatory agencies.
• Assist with the preparation of relevant components of NDA and other documents for regulatory submission.

• Work with CRO on all ongoing activities related to statistical analysis of clinical trial data; promptly alert data management of any issues noted which impact statistical deliverables.
• Support the review and write key project documents, including Case Report Forms and Statistical Analysis Plans.
• Serve as department representative on project teams.

• Master’s accepted with 3 years of industry experience; Ph.D. preferred
• Ability to build collaborative internal and external relationships
• Excellent oral and written communication skills
• Work independently with a sense of urgency and commitment to project timelines
• Proficiency in SAS programming and other statistical software
• Experience in anti-infectives and/or non-inferiority trials a plus
• Takes initiative to develop consensus and is able to positively manage challenge.
• Adopts and maintains the utmost integrity and respect for colleagues at all levels.
• Works proactively, effectively, and flexibly in a fast-paced, high change environment.
• Assumes responsibility and accountability for results; encourages team members to meet and exceed shared goals.
• Solicits feedback from others and takes action to improve performance.
• Willingness to "roll up one's sleeves" in order to achieve goals.
• Effective at time/project management: organized, provides input to development of team and individual project plans, prioritizes work activities and effectively manages time to meet goals and deadlines, constructively responds to obstacles to ensure achievement of objectives.