Principal Biostatistician FSP, Late Phase

Job Level: FSP Principal Biostatistician, Late Phase

Location: Home-based in the U.S. or Canada

Why DSSS?

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary:

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

Additional Benefits:

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high-performance, statistical and research teams.
• Technical training and tailored development curriculum.
• Research opportunities that match your unique skillset.
• Promising career trajectory.
• Job stability: long-term engagements and re-deployment opportunities.
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast-paced environment.
• Good work-life balance.

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
• Production 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, etc.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
• At least 3 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
• Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
• Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience in production programming of ADAM and TLF
• Experience with CDISC, including SDTM, ADAM, CDASH
• Solid understanding of multiple imputation methods

Desired Experience:

• Interaction with regulators including Advisory Committee meetings.
• 2+ years of experience with renal therapeutic or CNS area.

Note--We have Principal Statistician roles across all areas of FSP- Early Phase, Late Phase aligning to various Therapeutic studies.

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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. https://jobs.iqvia.com/eoe

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.