Principal Statistician

Flex and Oncology Clinical Research Private Limited; Ernakulam; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Lead Statistician to guide the design and analysis of clinical trials across multiple programs. You will develop SAPs, review study designs, and lead statistical consultancy for internal and sponsor teams, ensuring high-quality outputs and regulatory compliance.

The role requires hands‑on SAS proficiency, leadership, and strong communication for cross‑functional collaboration in a global CRO environment.

Qualifications

• Degree in a relevant field with hands‑on project statistics experience.
• Thorough knowledge of regulatory standards and FDA/ICH guidance.
• Excellent time management, organization, and English communication skills.

Responsibilities

• Review study designs, analysis plans, and reports.
• Design trials with statistical sections, randomization methods, and SAPs.
• Advise on core components of study design and analysis.
• Support statistics reporting: tables, figures, listings, and dataset specs.
• Prepare final reports and associated documentation.
• Develop, test, and run SAS programs for clinical data analysis.
• Create SDTM/ADaM datasets and related outputs.
• Manage ad hoc data summaries during trials.
• Extract summaries and study data as needed from systems.

Skills

SAS

Statistical leadership

Consultancy

English communication

Time management

Education

BSc

MSc

PhD

Tools

SAS

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:

Performs the lead statistician role, leading and contributing to the development and implementation of Statistical Analysis Plans, and providing statistical consultancy internally and externally to the company.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Provide review of study designs, analysis plans, and reports.
• Contribute to the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing Statistical Analysis Plans.
• Able to understand and advise on core components of study design and analysis.
• Provide support to the statistics reporting process through the specification/review of tables, figures, and listing shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations.
• Undertake and/or contribute to the preparation of final reports, including production of tables, figures, and listings and report writing.
• Develop, test, and run SAS programs for the statistical analysis of clinical study data.
• This includes programs for derived datasets, SDTM/ADaM datasets, tables, figures, and listings, and/or associated validation.
• Manage requests for ad hoc data summaries when requested during the course of a trial.
• Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets
• Contribute to the identification of system and process improvements, and to the development and implementation of solutions to improve the efficiency and quality of clinical study data processing and reporting.
• May make statistical contributions to manuscripts for publication.
• Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert and timely statistical consultancy and support
• May provide consultancy, mentoring, and guidance to statisticians on statistical methodological issues during trial design and analysis.
• Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
• Liaise with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements
• Represent the function externally through attending and participating in external sponsor team meetings or meetings with external vendors/conferences.
• Apply department knowledge of the latest developments in statistical methods, regulations (in particular ICH, FDA, CPMP points to consider efficacy, safety and quality standards) and software applications.
• Contribute to the development of statistical design and analysis policies
• Review budgets and flag any out of scope or unbudgeted items, identify any tasks not in alignment with current scope of work.
• Assist with Quality Assurance and Audit requirements.
• Assist the leadership of the department with all other aspects of the job, as required.
• 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:

• Must be computer literate and numerate with a proven ability to adapt to various computer systems; thorough knowledge of SAS; knowledge of other software applications a plus
• Consultancy and facilitation skills are required together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, and influencing, embracing innovation and change.

REQUIREMENTS:

Appropriate degree and minimum relevant experience: (BSc/8 years, MSc/6 years, PhD/4 years) Hands‑on expert level project statistician experienced in providing statistical leadership to projects. Experienced in a broad range of statistical applications across all phases of clinical research with a thorough knowledge of regulatory standards and exposure to regulatory interactions. Excellent Time Management skills with ability to develop, follow and direct project plans Good computer literacy with working knowledge of PCs, Windows, Microsoft Office Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English Ability to prioritize and handle multiple projects simultaneously, a flexible approach, the ability to use sound independent judgement and take initiative to assess information. Experience working within a team environment Experience across multiple therapeutic areas 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. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! 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. This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.