Principal Biostatistician FSP, Neuroscience

IQVIA • Durham, NC

22d • $115,900 - $243,900 • Remote

About The Position

The Principal Biostatistician is responsible for providing statistical support for novel neuroscience clinical research.

Requirements

• 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.

Nice To Haves

• Neuroscience experience

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees