Biostatistician II

Flex and Oncology Clinical Research Private Limited; Ernakulam; Hybrid; INR 1,400,000 - 2,200,000; Full time

Job summary

Worldwide Clinical Trials, a global midsize CRO, seeks a Biostatistician II to transform complex clinical trial data into meaningful insights across study design, analysis, and reporting. You’ll collaborate with project teams and external partners to ensure high-quality statistical outputs.

In this hybrid role based in India, you’ll own statistical deliverables, contribute to regulatory submissions, and provide technical guidance throughout the trial lifecycle.

Qualifications

• Master’s degree or higher in Biostatistics or a related field.
• Minimum 2 years of biostatistics experience; pharmaceutical research or CRO experience preferred.
• Knowledge of clinical trial design and methodologies.
• Experience developing statistical analysis plans, sample size calculations, randomization, and study specifications.
• Proficiency with statistical software packages and Microsoft Office Suite.
• Strong analytical, problem-solving, organizational and project management skills.
• Excellent written and verbal communication and cross-stakeholder collaboration.
• Proficiency in English.

Responsibilities

• Deliver statistical analyses and reporting on time and to quality standards.
• Provide guidance on study design, endpoints, sample size requirements, and methodology.
• Develop sample size calculations and randomization schemes.
• Author statistical analysis plans and study specifications.
• Serve as primary statistical contact for assigned studies and cross-functional teams.
• Program/review tables, listings, figures, and analysis datasets for trials.
• Support regulatory submissions with statistical deliverables and documentation.
• Conduct exploratory analyses and apply literature and regulatory guidance.

Skills

Clinical trial design

Statistical analysis

Study design guidance

Communication skills

Project management

English proficiency

Education

Master’s degree in Biostatistics or related field

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Join us!

Make an Impact as a Biostatistician II at Worldwide

As a Biostatistician II, you'll play a critical role in advancing clinical development programs by transforming complex clinical trial data into meaningful insights. Your expertise will help drive study design, statistical analysis, regulatory submissions, and data‑driven decision‑making that support the successful delivery of clinical research. Working as part of the Clinical Development Operations Biostatistics team, you'll collaborate with project teams and external partners to ensure high‑quality statistical analysis and reporting. You'll serve as a key statistical resource across studies, contributing technical expertise, scientific rigor, and strategic guidance throughout the clinical trial lifecycle. This is an opportunity to take ownership of statistical deliverables, influence study outcomes, and support the development of therapies through thoughtful analysis, collaboration, and problem‑solving.

Where You’ll Work

This is a hybrid role open to candidates based in India. You will collaborate with global teams across multiple time zones. Candidates are expected to work from the office at least once per quarter to support team collaboration, meetings, and business activities.

What You’ll Do

• Partner with project teams and vendors to deliver statistical analysis and reporting activities on time and to quality standards.
• Provide statistical guidance on study design, endpoints, sample size requirements, and analytical methodology.
• Develop sample size calculations, randomization schemes, and supporting documentation in accordance with established procedures.
• Author statistical analysis plans and study specifications that support clinical trial objectives.
• Serve as the primary statistical contact for assigned studies and provide expertise to cross‑functional project teams.
• Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials.
• Support regulatory submissions through the preparation and review of statistical deliverables and documentation.
• Conduct exploratory statistical analyses and apply scientific literature and regulatory guidance to support clinical development, publications, and presentations.
• Contribute to departmental initiatives and provide subject matter expertise to Biostatistics and Programming teams.

What You’ll Bring

• Master’s degree or higher in Biostatistics or a related field.
• Minimum 2 years of relevant biostatistics experience; pharmaceutical research or CRO experience preferred.
• Knowledge of clinical trial study design and clinical research methodologies.
• Experience developing statistical analysis plans, sample size calculations, randomization strategies, and study specifications.
• Proficiency with statistical software packages and Microsoft Office Suite.
• Strong analytical, problem‑solving, organizational, and project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills, strong interpersonal abilities, and experience collaborating with stakeholders across organizational levels.
• Proficiency in English.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.