Biostatistician II

Worldwide Clinical Trials; Ernakulam; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Worldwide Clinical Trials in India is seeking a BIostatistician II to join the Clinical Development Operations, Biostatistics team. You will plan, analyze, and summarize results of clinical studies and support regulatory submissions with statistical tables and datasets.

The candidate should have a Master’s degree in Biostatistics or related field and a minimum of two years of relevant CRO/pharmaceutical experience. Strong communication and project management skills are valued.

Qualifications

• Master's degree in Biostatistics or related field.
• Minimum 2 years of relevant work experience, CRO/pharma preferred.
• Strong written and oral communication, and ability to work independently.

Responsibilities

• Plan, analyze, and summarize results of clinical studies.
• Coordinate development and review of regulatory submissions.
• Program and review statistical tables, listings, figures, and analysis datasets.
• Provide sample size calculations and randomization schemes.
• Serve as project manager when no PM exists.
• Monitor budgets and forecast.
• Provide statistical advice on study design, endpoints, sample size, and methodology.
• Author statistical analysis plans.
• Liaise as primary statistical contact for study teams.
• Apply regulatory guidance to support programs.
• Present data for publications and presentations.

Skills

Biostatistics

Study design

Statistical software

Project management

Communication skills

Independent worker

Education

Master's degree in Biostatistics

Job description

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!

SUMMARY: The Biostatistician II is a key member of the Clinical Development Operations, Biostatistics Team. The Biostatistician will plan, analyze, and summarize the results of individual clinical studies or groups of studies, coordinate the development and review of regulatory submissions, and program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials.

RESPONSIBILITIES:

• Work with project team personnel and vendors to meet project deliverables and timelines for statistical data analysis and reporting.
• Provide sample size calculations and review protocols for completeness.
• Provide randomization schemes and appropriate documentation per SOPs.
• Monitor project budgets and support project forecasting efforts.
• Serve as project manager when a clinical development PM does not exist.
• Contribute to departmental initiatives.
• Serve as subject matter expert for the Biostatistics and Programming teams.
• Provide statistical advice regarding study design, endpoints, sample size requirements, and methodology.
• Author statistical analysis plans and study specifications.
• Serve as the primary statistical contact for the study/project team.
• Use knowledge of regulatory agency requirements and guidance documents to support clinical development programs.
• Use knowledge of literature to provide data analysis and presentation methods to support publications and presentations.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Knowledge of clinical trial study design.
• Able to work independently on multiple concurrent projects.
• Lead study team meetings as needed.
• Conduct exploratory statistical analyses using statistical software packages.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Ability to work within constantly changing priorities.
• Ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Good judgment with the ability to make timely and sound decisions.
• Ability to travel for meetings or training activities as needed.

REQUIREMENTS:

Education: Master's degree, equivalent, or higher in Biostatistics or a related field.

Experience: Minimum 2 years of relevant work experience. Pharmaceutical research or CRO experience preferred.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

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’reon a mission to hire thevery bestand 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.