FSP Principal Biostatistician, Safety Analytics

FSP Principal Biostatistician, Safety Analytics

Location: Home-based in the U.S. or Canada

Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

Job Summary

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.

Additional 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.

Job Responsibilities

• Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity, Injection/Infusion Site Reaction or other safety deliverables.
• Support Safety Analytics and the study team on the delivery of Patient Profile display for Hepatic or other areas.
• 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.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• 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.
• At least 2 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

Desired Experience

• Leading DSBM or DMC for biostatistics

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $111,000.00 - $309,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.