Principal Biostatistician (Heor/Hta)

0-2 years

Not Disclosed

Brazil Remote, USA

10 Feb. 7, 2025

Job Description

Job Type: Remote Education: Graduate degree in biostatistics or a related discipline Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Principal Biostatistician (HEOR/HTA)
Location: Brazil, Latin America (Home-Based)
Job ID: 25001623
Date Updated: February 5, 2025

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We aim to bring clinical, medical affairs, and commercial insights to life by addressing modern market realities. By placing customers and patients at the center of our work, we strive to simplify and streamline processes in order to enhance collaboration and achieve success in clinical development.

With a global workforce of 29,000 employees across 110 countries, Syneos Health is committed to fostering an inclusive, diverse, and supportive work environment.

Job Responsibilities

Leadership & Mentorship
- Serve as a resource for the statistical department.
- Mentor biostatisticians and develop training plans or materials for Biostatistics associates.
- Conduct training sessions and enhance the skills of existing personnel.
Project Oversight
- Direct the activities of biostatistics personnel to ensure timely, high-quality project completion.
- Independently review the work produced by other biostatisticians.
- Provide statistical support throughout the entire project lifecycle, from protocol development to clinical study report (CSR).
Statistical Analysis & Reporting
- Prepare and oversee Statistical Analysis Plans (SAPs).
- Collaborate with sponsors and other team members as needed.
- Lead statistical aspects of protocols, randomization schedules, and CSR contributions.
- Create or review programming specifications for analysis datasets, tables, listings, and figures.
Quality Assurance
- Review SAS annotated case report forms (CRFs) and database designs to ensure protocol requirements are met.
- Participate in verification and quality control of project deliverables.
- Ensure the output meets expected results and aligns with the analysis described in the SAP.
Project Management
- Manage scheduling and time constraints across multiple projects.
- Adapt to timeline or priority changes by reorganizing daily workload.
- Communicate any issues or difficulties meeting timelines to biostatistics management.
- Monitor progress on study activities to ensure milestones and deadlines are met.
- Identify out-of-scope tasks and escalate to management.
Regulatory & Business Development
- Support regulatory submissions, attend agency meetings, and provide statistical analysis support when needed.
- Contribute to proposals, budgets, and sponsor bid defense meetings.
- Assist with business development activities to support the growth of the company.

Qualifications

Required Experience
- Previous experience within HEOR (Health Economics and Outcomes Research) and/or HTA (Health Technology Assessment) is required.
- Extensive experience in clinical trials and ability to lead multiple projects.
- Proficiency in programming.
- Ability to apply statistical knowledge to clinical research and effectively communicate statistical concepts.
- Experience in all statistical tasks throughout the lifecycle of a clinical trial, from protocol to CSR.
Educational Requirements
- Graduate degree in biostatistics or a related discipline.
Additional Skills & Qualifications
- Strong written and verbal communication skills in English.
- Experience with regulatory submissions is preferred.
- Ability to work in a collaborative and dynamic environment.

About Syneos Health

Syneos Health is at the forefront of the biopharmaceutical industry, having worked on 94% of all Novel FDA-approved Drugs and 95% of EMA-authorized products in the past five years. Our projects span over 73,000 sites and have reached more than 675,000 trial patients globally.

Why Work with Us?

Career Development: Syneos Health offers continuous learning opportunities, technical and therapeutic training, and career progression.
Inclusive Culture: Our Total Self culture fosters authenticity and inclusivity, making Syneos Health a workplace where everyone feels they belong.
Global Impact: Be part of impactful projects that change the landscape of healthcare.

Additional Information

Travel: Minimal travel may be required.
Location Requirement: This role is open to candidates in Brazil, with eligibility for other countries in the specified regions (UK, Ireland, Greece, Hungary, Poland, Romania, South Africa, Spain, Ukraine, Argentina, Colombia, Mexico).
Equal Opportunity Employer: Syneos Health is committed to compliance with the Americans with Disabilities Act and applicable local employment regulations.

Apply Now or Join Our Talent Network to stay connected with future opportunities!

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Principal Biostatistician (Heor/Hta)

Job Description

Company Overview

Job Responsibilities

Qualifications

About Syneos Health

Why Work with Us?

Additional Information

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