Senior Biostatistician

ICON; Bengaluru; Híbrido; INR 3.000.000 - 5.500.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

Life assurance

Employee assistance program

Descripción de la vacante

ICON plc is seeking a Senior Biostatistician to lead statistical activities for programs and studies, interact with clients and regulators, and contribute to study design and reporting. The role involves SAS/R programming, budget preparation, and mentoring junior statisticians.

The candidate should have a Master's or PhD in Biostatistics and 6+ years of experience, with a track record in Phase II-III studies and regulatory interactions. Office or home-based in India with hybrid options.

Formación

• Master's degree OR Ph.D. in Biostatistics, Statistics, or a related field.
• 6+ years of biostatistical experience in either a CRO, pharmaceutical, or biotech company.
• Experience leading Phase II-III studies, including client facing responsibilities, timeline management, and resource oversight.
• Experience working in a clinical research organization preferred.
• Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications).
• Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies.
• Effective written and oral communication skills with demonstrated leadership ability.
• Ability to prioritize with strong time management skills

Responsabilidades

• Lead biostatistical activities for programs of studies, submissions, or on simple to complex individual studies.
• Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies.
• Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports.
• Program using SAS and/or R for inferential statistics.
• Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients.
• Participate in bid defense meetings and make presentations at marketing meetings with prospective clients.
• Mentor or provide support to junior statisticians.
• Lead or partake in initiatives to improve internal processes or create new guidance.

Conocimientos

Biostatistics

Regulatory experience

Project leadership

Clinical trials

Educación

Master's or PhD in Biostatistics

Herramientas

SAS

R

Descripción del empleo

Senior Biostatistician I / II - India - Office or Home

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Senior Biostatistician to join our diverse and dynamic team. As a Senior Biostatistician at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing:

• Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies

• Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies

• Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports

• Program using SAS and/or R for inferential statistics

• Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients

• Participate in bid defense meetings and make presentations at marketing meetings with prospective clients

• Mentor or provide support to junior statisticians

• Lead or partake in initiatives to improve internal processes or create new guidance

Your profile:

• Master's degree OR Ph.D. in Biostatistics, Statistics, or a related field

• 6+ years of biostatistical experience in either a CRO, pharmaceutical, or biotech company

• Experience leading Phase II-III studies, including client facing responsibilities, timeline management, and resource oversight

• Experience working in a clinical research organization preferred

• Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications)

• Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies

• Effective written and oral communication skills with demonstrated leadership ability

• Ability to prioritize with strong time management skills
  

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What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.