Principal Biostatistician (Heor/Hta)

0-1 years

Not Disclosed

Remote, USA South Africa

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: South Africa-Europe (Home-Based), ZAF

Job ID: 25001623

Date Updated: February 5, 2025

Company Overview

Syneos Health® is a leading biopharmaceutical solutions organization, built to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into actionable outcomes. We bring the customer and patient to the center of everything we do, and we work to simplify and streamline processes for enhanced collaboration and efficiency.

With over 29,000 employees across 110 countries, Syneos Health is passionate about making a global impact. We focus on developing our people through career development, supportive management, technical training, and a culture that celebrates diversity and inclusivity.

Job Responsibilities

Leadership and Mentorship: Serve as a statistical department resource, mentor biostatisticians, oversee training plans, and conduct training sessions.
Project Oversight: Manage activities of biostatistics personnel, ensuring timely completion and high-quality output.
Statistical Support: Provide support across all statistical tasks from protocol to Clinical Study Report (CSR), including the preparation of Statistical Analysis Plans (SAPs) and programming specifications.
Collaboration: Interface with other project team members, including sponsors, to develop and review study materials.
Data Management: Ensure correct data capture and quality by reviewing SAS annotated CRFs, database design, and study documentation.
Quality Control: Lead verification and quality control processes for project deliverables.
Regulatory Support: Attend regulatory meetings, provide statistical analysis results, and ensure submission readiness.
Project Management: Monitor progress against milestones, manage time constraints across multiple projects, and adjust workflows as necessary.
Business Development: Contribute to proposals, budgets, and bid defense meetings.

Required Qualifications

Experience:
- Previous experience in HEOR (Health Economics and Outcomes Research) and/or HTA (Health Technology Assessment) is required.
- Extensive experience in clinical trials, including leadership in multiple studies.
- Proficiency in statistical programming.
Education: Graduate degree in biostatistics or a related discipline.
Skills:
- Strong understanding of statistical design and analysis in clinical research.
- Experience with regulatory submissions is preferred.
- Excellent written and verbal communication skills in English.
- Ability to apply statistical techniques effectively in clinical trials.

Desired Skills

Ability to collaborate across various departments and stakeholders.
Experience in preparing and reviewing SAPs, programming specifications, and regulatory submissions.
Strong leadership qualities with the ability to mentor and guide junior biostatisticians.

Additional Information

Minimal travel may be required.
This position is open to candidates from the UK, Ireland, Greece, Hungary, Poland, Romania, South Africa, Spain, Ukraine, Argentina, Brazil, Colombia, and Mexico.
The company may assign additional tasks and responsibilities as needed.

Why Join Syneos Health?

Career Growth: Continuous development with career progression opportunities.
Inclusive Culture: Work in an environment that values diversity of thought, backgrounds, and cultures.
Global Impact: Contribute to the success of over 200 studies globally, supporting 94% of FDA-approved drugs.

At Syneos Health, we are dedicated to creating an environment where everyone can thrive. If your experience doesn't align perfectly with the job description, we encourage you to apply and explore transferable skills.

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

Required Qualifications

Desired Skills

Additional Information

Why Join Syneos Health?

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