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Senior Biostatistician – Center for Statistics in Drug Development – Bloemfontein

  • Bloemfontein
  • Anywhere

Senior Biostatistician – Center for Statistics in Drug Development

IQVIA

Bloemfontein, BEN

http://jobs.zeleus.com/49628E5CE09446AEBC86F035E22A7A9123

**Senior Biostatistician – Center for Statistics in Drug Development**

**Home-Based: Worldwide**

**Decision Sciences**

IQVIA’s Center for Statistics in Drug Development (CSDD) group is hiring!

This is a boutique expert statistical consulting group advising on exciting opportunities within IQVIA’s Core Services Research and Development Business unit.

Apart of the larger Biostatistics Team, this statistical research team is unique in its emphasis to develop optimal strategies to best navigate the complexities of clinical development, support building innovative and optimized trial designs, and facilitate decision-making throughout clinical development.

Our biostatisticians support endpoint selection, sample size estimation and re-estimation, simulations, advise on state-of-the art design approaches and analysis methods, and assist with data displays and interpretations of data analysis results, based on machine learning or other complex data analyses. Our experienced biostatisticians serve as statistical consultants, both internally and externally, provide statistical thought leadership, and advise on advanced statistical methods.

Their early engagement aims to identify gaps in the drug development strategy and in proposed study designs — at the time of synopsis writing.

The CSDD group’s expertise in design types include biosimilars, adaptive designs, seamless designs, dose-response designs, master protocols, Bayesian methods and analyses.

This group engages in publishing papers in peer-reviewed journals, refereeing and editorial work, and presenting talks at scientific conferences and at internal and external webinars.

**Job Overview:**

Develop statistical methods sections of protocols and review case report forms (CRFs).

Prepare analysis plans and write specifications for analysis files, tables, and figures.

Communicate with clients regarding study protocol or statistical analysis issues as they arise and communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.

Interpret analyses and write statistical sections of study reports.

Accountable for controlling costs and maximizing revenue recognition.

+ Performing protocol development, sample size calculation and CRF’s review’s

+ Acting as a statistical team lead for single, complex studies or groups of studies

+ Coordinating the development of statistical analysis plans, table shells, and programming specifications

+ Managing scope of work and budget, providing revenue and resource forecasts

+ Consulting on operational, statistical, and therapeutic area topics

+ Preparing proposal text and attend bid defense meetings if needed

+ Acting as a primary point of contact for the study team – communicate with team members regarding execution as it relates to timelines, budget, data quality, and interpretation of results

+ Providing expert statistical input and review of deliverables for validation requirements

+ Reviewing of the clinical study report to ensure statistical integrity in the reporting of the results

+ Interpreting analysis and crafting statistical sections of integrated reports

+ Providing training and mentoring to team members and department staff

**Requirements:**

+ PhD or MSc degree in Statistics, Biostatistics, or related field, along with 5 + years’ experience within the life-science industry, PhD preferred.

+ Strong knowledge of complex or advanced statistical methods and good expertise in implementing and applying them in clinical trials

+ Must have experience with clinical trial design, adaptive design strongly preferred

+ Must have solid work experience in regulatory health authorities’ environment (FDA, EMEA,…) and with compliance within the pharmaceutical and CRO space.

+ Strong working knowledge of SAS or R and CDISC SDTM and ADaM

+ Ability to effectively manage multiple tasks and projects, ability to excel at communicating and explaining statistical concepts

From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues.

**JOIN US**

Embrace your curiosity and grow your career in an exciting environment where development is a priority.

Think boldly and disrupt conventional thinking.

Enjoy what you do.

**Whatever your career goals, we are here to ensure you get there!**

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

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