Biostatistician II - Early Development Studies

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Biostatistician I/II

Thermo Fisher Scientific offers the scale, reach, and mission-driven work to make a meaningful impact in clinical research and development.

DESCRIPTION

How you will make an impact

You will function independently as a lead statistician to deliver critical project statistician tasks and responsibilities, including statistical analyses, development of table, listing and figure specifications, and review of formatted datasets and statistical results, tables, listings and figures.

What you will do

Ensure compliance with the activities outlined in the department's SOPs. Follow departmental procedures for statistical analyses and programming work.

Lead a project team. Conduct team meetings, maintain project timelines, assess resources needed, provide resources, and prepare the budget. Ensure that SOPs are being followed and that appropriate project documentation is ongoing.

Interact with the sponsor on all aspects of the project.

Coordinate with programmers and data management personnel as to database maintenance, updating and documentation. Provide guidance for database structures for analysis.

Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis.

Provide randomization schemes and appropriate documentation.

Develop statistical analysis plans, including table, listing and figure specifications.

Perform SAS programming to support statistical analyses, including the preparation of analysis-specific datasets and implementation of statistical models. Review formatted datasets and statistical results, tables, listings and figures.

Review reports and other documents and manuscripts. Contribute to the statistical methods section and verify for completeness and consistency.

Monitor project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.

Requirements

How you will get here

Education and Experience

Master's degree in statistics, biostatistics, mathematics or related field.

2+ years of experience working in Biostatistics. Previous CRO experience is desirable.

In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient.

Knowledge, Skills and Abilities

Solid SAS® programming experience (proficient in BASE, STAT, MACRO and GRAPH), with working knowledge of statistical modeling in SAS; knowledge of R would be an advantage.

Solid understanding of statistical principles and good statistical skills.

Capable of creating table, listing and figure specifications and providing support in the review of study deliverables.

Good project management skills as shown through management of multiple studies.

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

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

Capable of promoting teamwork in a multi-disciplinary and global team setting.

Positive attitude and the ability to work well with others.

Working Conditions

This is a remote/work-from-home position based in the Philippines.

Flexibility in working hours may be required to accommodate collaboration and meetings within a global organization. Additional flexibility may be required during the initial onboarding and training period to ensure sufficient overlap with international team members.