Senior Biostatistician

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Operate autonomously as a lead statistician with minimal supervision.

• Execute project statistician responsibilities, which include the creation of analysis databases, conducting statistical analyses, and generating formatted statistical analysis tables and summaries.

• Guide and mentor junior team members while offering project direction and statistical counsel.

• Ensure adherence to departmental standard operating procedures (SOPs) and protocols.

• Take charge of intricate projects and conduct senior project reviews.

• Engage with sponsors and deliver presentations to sponsors and regulatory bodies as required.

• Evaluate sample size calculations, research protocols, clinical designs, statistical analyses, and randomization documents.

• Compose and assess analysis plans while determining suitable statistical analysis methods and procedures.

• Review specifications and manage the development and upkeep of analysis databases.

• Supervise collaboration with programming and data management teams.

• Oversee the creation of specifications for tables and listings.

• Draft reports, manuscripts, and related documents.

• Contribute to the statistical methods sections for comprehensive clinical, safety, and efficacy reports.

• Monitor project budgets and notify management and sponsors of any changes in scope or budget.

• Offer insights on hiring recommendations, departmental policies, and resource needs.

• Act as a representative of the department to other divisions.

• Support bidding and business development initiatives, including proposal submissions and timelines.

⛳️ Requirements

• A minimum of a Master's degree in Biostatistics, Statistics, or Mathematics is required.

• An equivalent combination of relevant education, training, and/or directly related experience may be considered adequate.

• Prior experience equivalent to at least 4 years is necessary.

• Experience in a project lead role with client-facing responsibilities is essential.

• Proficiency in programming with SAS and R is mandatory.

• Extensive skills in SAS programming (BASE, STAT, MACRO, and GRAPH) are required.

• A thorough understanding of various clinical trials/designs and the associated data reporting is essential.

• Profound knowledge in interpreting results from statistical analyses of complex datasets is required.

• Strong project management capabilities, including the ability to manage multiple projects simultaneously.

• Exceptional written and verbal communication skills, with a high level of proficiency in English.

• Significant organizational, time management, and planning abilities.

• Strong interpersonal skills with the capacity to collaborate effectively within a team setting.

• Must possess legal authorization to work in the US without sponsorship.

• Must successfully pass a comprehensive background check, including drug testing.

🏝️ Benefits

• Relocation assistance is NOT provided.

• We are an equal employment opportunity and affirmative action employer.

• Reasonable accommodations are available for individuals with disabilities.

• Accessibility services are offered for job seekers needing accommodations.

• Standard work schedule is Monday to Friday.