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.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.