Principal Statistician

Worldwide Clinical Trials; Ernakulam; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Worldwide Clinical Trials seeks a lead statistician to guide development and implementation of Statistical Analysis Plans, and provide statistical consultancy internal and external.

The role involves reviewing study designs, writing SAPs, designing trial statistics, and mentoring other statisticians while ensuring compliance with FDA/ICH quality standards and company policies.

Qualifications

• Appropriate degree and minimum experience: BSc/8 years, MSc/6 years, PhD/4 years.
• Hands-on expert level project statistician with leadership to projects.
• Experience across regulatory standards and regulatory interactions.

Responsibilities

• Review study designs, analysis plans, and reports.
• Design trials' statistical sections and SAPs; advise on study design components.
• Develop, test, and run SAS programs for analysis of clinical data.
• Provide statistics support and mentorship across projects.

Skills

SAS programming

Statistical leadership

Study design review

Regulatory knowledge

Statistical consultancy

Mentoring statisticians

Education

BSc with 8 years

MSc with 6 years

PhD with 4 years

Tools

SAS

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:

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 setsContribute 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 supportMay 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 requirementsRepresent 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 policiesReview 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 plusConsultancy 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 plansGood computer literacy with working knowledge of PCs, Windows, Microsoft OfficeGood oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in EnglishAbility 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 environmentExperience across multiple therapeutic areasPromotion 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’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.