Amgen
Associate Director Biostatistics
Taiwan · On-site · Full time
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerAmgen
- LocationTaiwan
- Work styleOn-site
- Employment typeFull time
- Employer posted
Career Category
Clinical Development
Job Description
What you will do
Amgen is expanding its global Biostatistics capabilities, with Amgen Taiwan playing a key role in integrated delivery and functional leadership. As Associate Director, Biostatistics, you will contribute statistical strategy, operational execution, and scientific leadership across Amgen’s clinical programs. You will oversee statistical contributions to clinical trials, lead study teams, and support regulatory and reimbursement submissions, while mentoring and managing statisticians. Throughcross-country and cross-functional collaborations, you will have the opportunity to contribute to innovative technologies that enhance scientific and/or operational efficiencies in drug development.
This role provides both hands-on technical leadership and managerial responsibility, ensuring quality, compliance, and innovation in biostatistical delivery aligned with Amgen’s global clinical development strategy.
Show full description
Responsibilities:
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
- Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents.
- Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies.
- Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings.
- Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives.
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs.
- Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents.
- Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies.
- Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings.
- Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives.
- Execute biostatistical strategies across the product lifecycle, from early development through post-marketing.
- Provide consultancy and training to colleagues across R&D.
- Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance.
- Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees).
- Drive technology adoption leveraging AI capabilities to streamline statistician’s work
Basic Qualifications
- Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
- Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Successful managerial experience of a group of statisticians and statistical programmers.
Preferred Skills
- Doctorate in Statistics/Biostatistics (or related subject such as data science, engineering with high statistical content) with at least 7 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
- Master’s degree in Statistics/Biostatistics (or related subject such as data science, engineering with high statistical content) with at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Experience developing interactive or advanced visualizations to enhance interpretation of clinical trial data is a plus. Familiarity with R or Python is preferred.
- Prior experience in growing a successful team of statisticians within Clinical Development
.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Work styleOn-site
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked
Skills in this posting
Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.