The job is based in Wilmington Delaware, US. (Minimum 3 days per week in the office. Local candidates or those willing to relocate only).

Job Summary (Primary function)

This role is responsible for processing clinical data required for statistical analysis of Phase I - III clinical trials and leading project teams.

Essential Functions of the Job (Key responsibilities)
• Other responsibilities as required.
• Participate in the development and enforcement of SOPs and guidelines.
• Participate in pre-IND and NDA activities.
• Participate and contribute to authoring of Clinical Development Plan.
• Assist in writing relevant sections of the clinical study report.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Provide guidance and support to team members in creating analysis dataset specifications and programming of tables, listings, and figures.
• Write statistical analysis plans.
• Provide statistical input to study protocols.
• Interact with members of the multidisciplinary project teams to establish project timelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• PhD in Statistics/biostatistics, Working experience in pharma/biotech, hands on working experience in clinical trials
• Strong technical background for statistical methodology work
• Proficiency in using SAS to perform efficacy analyses and validate important data derivations when necessary
• Familiarity with multivariate analyses and biomarker analyses is beneficial.
• Experience in collaborating with health authorities, including discussions and negotiations in filing strategies, is highly valued. Able to effectively communicate their ideas and to manage team members in a constructive manner.
• Demonstrate ability to work autonomously in project management and decision making.
• Several years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
• Advanced degree in statistics or equivalent experience preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.