Senior Director, Novel Trial Design Solutions Group/Lead Biostatistician

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Job Profile Summary 

This senior biostatistical scientist will be responsible for strategic biostatistical input on Novel Trial Design opportunities. 

Responsibilities

• Provide strategic biostatistical input with special focus on Novel Trial Design opportunities, to high priority sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of success for drugs development by pharmaceutical companies.

• Become aware and remain familiar with new developments in areas of statistical design or analysis carried out by the Strategic Biostatistics Unit and Novel Trial Design Solutions Group that can be used to give IQVIA a greater edge over competitors.

• Represent IQVIA and its Clients at FDA or EMEA meetings

• Market IQVIA strategic biostatistical expertise in the Novel Trial space, that may include: (i) publishing papers (where advantageous to IQVIA) that demonstrate strategic bios expertise in key areas (such as adaptive design); (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business; (iii) and publicizing internally to key groups.

• Maintain knowledge and awareness of developments in biostatistics, clinical trial methodology, and regulatory requirements that impact on design or analyses for multiple therapeutic areas.

• Market IQVIA strategic biostatistical expertise in the Novel Trial space, that may include: (i) publishing papers (where advantageous to IQVIA) that demonstrate strategic bios expertise in key areas (such as adaptive design); (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business; (iii) and publicizing internally to key groups.

• Provide strategic biostatistical input at the study level (and in some cases, provide input on general drug development) to proposals and sales opportunities to help increase revenue for IQVIA.

• Provide strategic biostatistical input at the study level (and in some cases, provide input on general drug development) to those companies currently working in partnership with IQVIA, with the aim of helping retain existing business and winning further business; as well as provide such input for other key projects where this can lead to large awards in the future. Represent such clients at meetings with FDA or European regulatory authorities.

• Participate in the provision of training within Global Biostatistics and Novel Trial Design Solutions Group on advanced statistical topics or advanced case studies. Participate in the provision of high-level statistical consultancy provided to Biostatistics staff within IQVIA.

• Support software development in adaptive designs, and master protocols.

• Provide thought leadership in the area of Novel Trial Designs, including making presentations at conferences and in webinars.

• Support development of new adaptive designs, and related trials, including interacting with pharmacokineticists on pediatric extension studies, precision dosing opportunities, and personalized and precision medicine.

Minimum Required Education and Experience

To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the Responsibilities.

Experience
Typically requires a minimum of 10 years of prior relevant experience.

Knowledge
Requires exceptional business knowledge to drive results for the organization.

Applies extensive business and industry expertise and provides organizational thought leadership.

Education
Advanced degree in Biostatistics or related discipline             

Additional Work Experience     12 years of experience working on clinical trials with 8 years of experience in a leadership capacity supporting clients and new business or Equivalent combination of education, training and experience.            

Skills and Abilities
    - In depth knowledge of the drug development processes across all functional areas. 

• Ability to apply advanced Biostatistical methods in novel trial designs through consultative interaction with customers.

Familiarity with master protocols, adaptive designs, and hybrid real-world studies.       
    - Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.        
    Strong client management skills.        
    - Strong leadership skills.        
    - Effective presentation skills.        
    - Proficient in the use of Microsoft Office.        
    - Strong written and verbal communication skills including good command of English.        
    - Excellent organizational and problem-solving skills.        
    - Effective time management skills and ability to manage competing priorities.        
    - Expert ability to analyze metrics and information; ensuring activities and strategies are data driven.        
    - Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.