Principal Biostatistician FSP, Late Phase

The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.

Job Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Author statistical analysis plans.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Author or review analysis dataset and TLF specifications.
• Validate programming of efficacy analysis datasets plus tables, listings, and figures (TLF).
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in IND or NDA activities.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).

Qualifications

• PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• At least 2 years in Phase 2/3 clinical trial experience.
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate ideas and collaborate with cross-functional teams.
• Able to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
• Support of various regulatory submissions.
• Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience in validation/programming of ADAM and TLF.
• Experience with CDISC, including SDTM, ADAM, CDASH.
• Solid understanding of estimands and multiple imputation methods.

Desired Experience

• Supporting written communications with regulators.
• 1+ years of experience with immunology therapeutic area.
• Bayesian methods

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $115,900.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.