FSP Principal Biostatistician- Early Phase Clinical Development(PK)

IQVIA•Durham, NC

5d•Remote

About The Position

The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases of development, focusing on healthy normal studies with PK and PD endpoints.

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 non-compartmental PK endpoints in pharmaceutical industry
Understanding of ICH GCP, regulatory guidance for clinical pharmacology studies and industry practices/standards.
Experience with CDISC, including SDTM, ADaM, CDASH.
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.

Nice To Haves

Knowledge of basic statistical modeling, simulations and PD/biomarker analyses

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, including sample size calculations, while consulting with internal and external experts.
Review eCRF and other data management documents.
Create or review randomizations and related specifications.
Write or review statistical analysis plans, dataset and TLF specifications.
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
Provide statistical review and validation of the same.
Use SAS and/or R to perform inferential analyses and validate key data derivations.
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/PK with statistical expertise.
Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc.
Support exploratory analyses.
May support IND activities.

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 on project budgets and change orders
Engaging, fast-paced environment
Good work-life balance