Senior Biostatistician FSP, Pharmacokinetics

$115,900 - $193,100/Yr

Quintiles - Durham, NC

Part-time - Principal

Remote - Durham, NC

Ambulatory Health Care Services

About the position

The Principal Biostatistician for Early Phase Clinical Development is responsible for providing statistical support for drug development programs, particularly focusing on healthy normal studies with pharmacokinetic (PK) and pharmacodynamic (PD) endpoints. This role involves collaboration with multidisciplinary project teams, contributing to clinical trial protocols, and ensuring the accuracy of study results while working in a fast-paced, engaging environment.

Responsibilities

• Collaborate with multidisciplinary project teams to establish project timelines.
• Provide statistical input to study synopses and protocols.
• Write the statistical sections of clinical trial protocols, consulting with internal and external experts.
• Write or review statistical analysis plans, dataset, and TLF specifications.
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming of tables, listings, and figures.
• Interpret study results and review reports of study results for accuracy.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists with statistical expertise.
• Contribute to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
• Support exploratory analyses and publications.
• Participate in pre-IND and NDA activities.
• Participate in other activities and meetings to support Biostatistics and the Development Team as needed.
• Demonstrate the ability to work independently in project management and decision making.
• Effectively communicate statistical concepts to colleagues.
• Effectively manage CROs.
• Use SAS and/or R to perform inferential analyses and validate important data derivations when necessary.

Requirements

• PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• 2+ years of experience in statistical analysis of PK and PD endpoints in the pharmaceutical industry.
• 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.
• Knowledge of simulations, multivariate analyses, and biomarker analyses.

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