Principal Biostatistician FSP, Neuroscience

Job Level: FSP Principal Biostatistician for Neuroscience Clinical Research

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 means you get all the benefits of working for an industry leading global CRO while collaborating directly with expert 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 novel neuroscience clinical research.

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.
• Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Write statistical analysis plans.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Contribute to clinical study/statistical reports and other regulatory documents.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses and medical affairs publications.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

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

• PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
• At least 3 years in clinical trial experience in phase 2 and 3 plus 2 years in observational/RWE studies.
• Demonstrated ability to work independently in project management and decision making.
• Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
• Proficiency in SAS to perform analyses and validate important data derivations.
• Performing sample-size/power calculations.
• Performing clinical trial simulations.
• Performing detailed literature reviews and summarization for epidemiologic data.
• Performing validation of Endpoints/Outcomes to inform study design.
• Experience with applying innovative study design and analytic techniques such as synthetic control arms, causal inference methods, rare disease methods, Bayesian techniques.
• Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, ADAM, CDASH.

Desired Experience:

• Neuroscience experience
• No further specialized skills are applicable.

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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 protect