Principal Biostatistician FSP, Early Phase

IQVIA • Durham, NC

12d • Remote

About The Position

The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases.

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.
• Early Phase Oncology experience is PREFERRED.
• Experience to help with dose escalation studies, efficacy endpoints and solid tumor.
• 1+ years with regulatory submissions
• Successful publication experience.
• Demonstrate 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.
• Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Experience with CDISC, including SDTM, Adam, CDASH

Nice To Haves

• Familiarity with R programming language and other statistical software, including EAST.
• Experience with Bayesian methods
• Knowledge of simulations, multivariate analyses, and biomarker analyses

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project timelines.
• Provide statistical input to study protocols.
• Writes 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.
• Collaborates with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
• 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.
• Participate and contribute to authoring of Clinical Development Plan.
• Support exploratory analyses and medical affairs publications.
• Participate in pre-IND and NDA activities.
• 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