Work Schedule

Environmental Conditions

Job Description

As a Biostatistician II, you will function independently as a lead statistician with minimal oversight, delivering project statistician tasks and responsibilities including analysis database creation, statistical analyses, and the development of formatted statistical analysis tables and summaries. You will also provide mentorship and guidance to junior team members.

Essential Functions and Other Job Information

• Ensure compliance with activities outlined in departmental Standard Operating Procedures (SOPs) and follow established procedures for statistical analyses and programming activities.

• Lead project teams, including conducting team meetings, maintaining project timelines, assessing resource requirements, allocating resources, and preparing project budgets. Ensure adherence to SOPs and appropriate ongoing project documentation.

• Interact directly with sponsors on all statistical aspects of assigned projects.

• Coordinate with programmers and data management personnel regarding database maintenance, updates, and documentation. Provide guidance on database structures required for statistical analyses.

• Perform sample size calculations and review protocols for completeness, appropriateness of clinical study design, and sound statistical methodology.

• Develop randomization schemes and associated documentation.

• Develop statistical analysis plans, including analysis database specifications and table and listing specifications, and guide project team members in their implementation.

• Program and/or validate statistical tables, with an emphasis on efficacy endpoints. Ensure appropriate documentation and oversee team members supporting programming and validation activities.

• Review reports, documents, and manuscripts. Contribute to statistical methods sections and verify reports for statistical completeness and consistency.

• Monitor project budgets in relation to project scope and proactively communicate potential scope changes to management.

• Provide general infrastructure support to the department. Activities may include delivering presentations or training, contributing to departmental documents and policies, supporting newsletters or departmental libraries, and assisting with the training and onboarding of new hires.

Qualifications

Education and Experience

• Master’s degree in Statistics, Biostatistics, Mathematics, or a related field.

• Previous experience providing the knowledge, skills, and abilities required to perform the role, typically equivalent to 2+ years of relevant experience.

Knowledge, Skills and Abilities

• Solid SAS® programming skills, including proficiency in BASE, STAT, MACRO, and GRAPH, with a strong understanding of database structures.

• Solid understanding of statistical principles and demonstrated statistical skills.

• Ability to provide mentorship and promote effective teamwork within a multidisciplinary environment.

• Ability to develop study specifications and support the review of data management documentation.

• Good project management skills, demonstrated through the successful management of multiple projects and priorities.

• Strong written and verbal communication skills, including proficiency in the English language.

• Good organizational skills, with the ability to adapt and adjust to changing priorities.

• Positive, collaborative approach and the ability to work effectively with colleagues, project teams, and sponsors.