Principal Biostatistician

At Emerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncologyareas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster resultsbringing therapies to patients in need.

Why Join Us

At our core, Emerald Clinical is committed to transforming clinical research by putting people firstboth patients and our employees. By joining our team, you'll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here's what makes us stand out:

Purpose-Driven Work: You'll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.

Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.

Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

About the Role

The Principal Biostatistician is responsible for Emerald Clinical projects by performing statistical programming and biostats activities as directed by senior management or statistical services lead at Emerald Clinical.

Your Responsibilities

Perform, plan co-ordinate, and implement the following for complex studies:

o Participate as biostatistician on project(s) including but not limited to reviewing protocols, preparing analysis plans, randomization plan, and writing sections of joint clinical/statistical reports.

o The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures and listings. o Giving inputs to protocol writing for stats section and sample size estimation and power calculations. o Programming SDTM datasets.

o Programming analysis datasets (derived datasets including efficacy datasets) and transfer files for internal and external clients.

o The programming quality control checks for the source data and report the data issues periodically o Participating in DSMC/DSMB o Answering queries from regulatory authorities.

Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.

Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.

Directly communicate with internal team including data management, project management, and client statisticians and client team members to ensure appropriate understanding of requirements and project timelines.

Use and promote the use of established standards, SOP and best practice.

Participate in project meetings; keep up-to-date on project issues.

Training, Quality and Compliance

Complete mandatory training for this role within specified timelines

Attend mandatory training sessions required for this role

Identify resources and training to support learning and development within this role

Comply with all applicable regulations, guidelines, SOPs and project-specific requirements

Comply with all designated systems relevant to this role

Ensure own quality control of all relevant processes and activities performed

Report and escalate identified risks and issues in areas of responsibility according to Emerald Clinical and/or project requirements.

Customer Focus and Teamwork

Attend and actively participate in Emerald Clinical meetings and other internal

meetings and activities as required

Provide input to systems, tools and processes to support continuous improvement

Share knowledge with others, to facilitate learning and development across the

organization

Work Health and Safety

Comply with Work Health & Safety (WH&S) legislation and operate in accordance

with established organisational WH&S practice and procedures

Promote and contribute to a safe, secure environment for staff and visitors

Education and Experience

M.Sc or Ph.D. in Biostatistics, Maths or science related field

Minimum 6 years experience with statistical programming and/or 10 years in the

Biostatistics or related work in the CRO environment

Minimum 10 years experience as biostatistician in the CRO/Pharma environment.

Competencies

Technological proficiency in SAS

Ability and motivated to learn and develop

Good team work and willing to help other team members.

Technological proficiency including Microsoft Office packages

Ability to see the big picture, yet still focus on detail and quality of work

Ability to be flexible and adaptable in the face of changing organisational priorities

and ambiguous environments

What We Offer

We understand that great work happens when people feel valued and supported. That's why we provide:

Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.

Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.

Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.

Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.

Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

Interested Apply now and help us achieve our mission to improve the health of millions worldwide.