FSP Principal Biostatistician, Safety Analytics

IQVIA•Durham, NC

2d•Remote

About The Position

The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes.

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 5 years of Phase 1, 2 and 3 clinical trial experience.
Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
R/SAS programming skills
Demonstrated ability to work pro-actively and independently.
Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
Experience with CDISC, including SDTM, ADAM, CDASH

Nice To Haves

Leading DSBM or DMC for biostatistics

Responsibilities

Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables.
Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display.
Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs.
Interrogating root cause of issues identified during ADaM/TFL/Interactive package review
Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials.
Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
Participating in study design discussions, including protocol development
Write the statistical sections of clinical trial protocols.
Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed.
Developing and reviewing statistical analysis plans and TFL templates.
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 reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
Perform exploratory safety analyses
Perform validation of analysis variables and statistical outputs
Interpret study results and review reports of study results for accuracy.
Present, communicate and interpret safety analyses to study teams
Support exploratory analyses.
Participate in pre-IND or NDA 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 project budgets and change orders.
Experience with regulatory submissions.
Engaging, fast-paced environment.
Good work-life balance.