Biostatistics Medical Writer

Clario

19h

About The Position

At Clario, a part of Thermo Fisher Scientific, we are driven by a shared mission to transform lives by advancing clinical research through innovation, expertise, and collaboration. The Biostatistics Medical Writer plays a key role in supporting cardiac safety and clinical trial reporting by partnering closely with Statistical and Scientific teams to deliver high-quality, compliant scientific documents for global sponsors. This role is responsible for developing Expert Cardiac Safety Reports and Statistical Analysis Plans, as well as contributing to synopsis and protocol development. The position requires strong scientific writing skills, attention to detail, and the ability to manage deliverables in a regulated, fast-paced environment while maintaining high-quality standards.

Requirements

A degree in Science or Healthcare Related Field and 4+ years relevant industry experience
Previous experience in medical or scientific writing for publications, reports, or grant submissions
Knowledge of clinical trials environment and regulation
Experience in clinical trials within a CRO or pharmaceutical research organization
Ability to interpret statistical outputs (tables, figures, and listings) and write clear, concise descriptions of results.
Fluency with statistical concepts and medical terminology.
Knowledge of AMA style or demonstrated ability to learn and follow a style guide.
Familiarity with Clinical protocols and Statistical Analysis Plans, understanding of the pharmaceutical drug development process
Excellent verbal and written communication skills
Strong organization, analytical and communication skills.
Experience with Windows, Microsoft Office and Adobe products.
Ability to learn quickly, function independently, and handle increasing levels of responsibility.
Familiarity with Clario products and service lines.
Ability to work in a group setting and independently, adjusting to rapidly changing priorities.

Responsibilities

Create, edit/proofread, and finalize Expert Cardiac Safety Reports based on the output of the statistical analysis (Tables, Listings, and Figures) and the final conclusions of the Scientific team
Work with the Statistical team to create, edit/proofread, and finalize the Statistical Analysis Plan(s)
Manage Individual assigned project tasks and timelines once a study reaches the scientific reporting phase
Interpret and incorporate key information from the appropriate source documents (e.g., study protocol, investigator’s brochure, scope of work, and internal study plan documents)
Use subject area knowledge of clinical trial design, Clario products, and standard statistical analyses methods to write background sections of documents
Insert statistical outputs into reports, interpret results, and write text for results sections, discussion, and summary as directed by the subject matter expert and/or statistical team, and circulate internally for review
Edit, format, create and check hyperlinks, and perform medical writing quality control check of documents prior to sharing with the client
Anticipate challenges or delays, and communicate status to project managers and statistical/scientific team
Contribute to the team-level tracker
Lead the medical writing aspects of the document revision process, both internally and with clients, including participating in teleconferences with clients as requested
Work with the Statistical and Scientific teams to help sponsors with the development of synopsis and protocols for the cardiac safety component
Overall management of Medical Writing timelines of all deliverables in terms of Expert Cardiac Safety Reports, Statistical Analysis Plans, and other outputs as needed.
Understand FDA/EMA regulations in regard to clinical trial reporting
Create and maintain document templates and an internal style guide with standards based on industry best practices AMA style guide, and ICH/FDA/EMA guidance and regulations, as well as train and instruct the team in the use of templates and guidelines
Lead or Attend regularly scheduled cross-functional planning meetings
Contribute to manuscripts and/or scientific presentations through ongoing medical writing support
Train new team members and perform other duties, assignments, or special projects as time and/or circumstances necessitate
Evaluate department strategy, identify gaps, and initiate improvements in document creation processes
Conduct onboarding and training on Medical Writing team/practices of staff
Assist with the development, coordination, maintenance & enforcement of quality standard compliance, including creating SOPs, SWIs, Playbook/Checklists and Templates for team deliverables