FSP Principal Biostatistician, Safety Analytics
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.
Responsibilities
ā¢ Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables.
ā¢ Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display.
ā¢ Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs.
ā¢ Interrogating root cause of issues identified during ADaM/TFL/Interactive package review
ā¢ Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials.
ā¢ Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
ā¢ Participating in study design discussions, including protocol development
ā¢ Write the statistical sections of clinical trial protocols.
ā¢ Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed.
ā¢ Developing and reviewing statistical analysis plans and TFL templates.
ā¢ Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
ā¢ Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
ā¢ Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
ā¢ Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
ā¢ Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
ā¢ Perform exploratory safety analyses
ā¢ Perform validation of analysis variables and statistical outputs
ā¢ Interpret study results and review reports of study results for accuracy.
ā¢ Present, communicate and interpret safety analyses to study teams
ā¢ Support exploratory analyses.
ā¢ Participate in pre-IND or NDA activities.
Requirements
ā¢ PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
ā¢ MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
ā¢ At least 5 years of Phase 1, 2 and 3 clinical trial experience.
ā¢ Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
ā¢ Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
ā¢ Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
ā¢ Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
ā¢ R/SAS programming skills
ā¢ Demonstrated ability to work pro-actively and independently.
ā¢ Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
ā¢ Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
ā¢ Experience with CDISC, including SDTM, ADAM, CDASH
Nice-to-haves
ā¢ Leading DSBM or DMC for biostatistics
Benefits
ā¢ Home-based remote working opportunities.
ā¢ Work/life balance as well as flexible schedules.
ā¢ Collaborating with motivated, high-performance, statistical and research teams.
ā¢ Technical training and tailored development curriculum.
ā¢ Research opportunities that match your unique skillset.
ā¢ Promising career trajectory.
ā¢ Job stability: long-term engagements and re-deployment opportunities.
ā¢ Focus on bringing new therapies to market rather than project budgets and change orders.
ā¢ Experience with regulatory submissions.
ā¢ Engaging, fast-paced environment.
ā¢ Good work-life balance.
Apply tot his job
Apply To this Job
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.
Responsibilities
ā¢ Support Safety Analytics with ADaM/TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables.
ā¢ Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display.
ā¢ Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs.
ā¢ Interrogating root cause of issues identified during ADaM/TFL/Interactive package review
ā¢ Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials.
ā¢ Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
ā¢ Participating in study design discussions, including protocol development
ā¢ Write the statistical sections of clinical trial protocols.
ā¢ Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed.
ā¢ Developing and reviewing statistical analysis plans and TFL templates.
ā¢ Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
ā¢ Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
ā¢ Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc.
ā¢ Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements.
ā¢ Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures.
ā¢ Perform exploratory safety analyses
ā¢ Perform validation of analysis variables and statistical outputs
ā¢ Interpret study results and review reports of study results for accuracy.
ā¢ Present, communicate and interpret safety analyses to study teams
ā¢ Support exploratory analyses.
ā¢ Participate in pre-IND or NDA activities.
Requirements
ā¢ PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
ā¢ MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
ā¢ At least 5 years of Phase 1, 2 and 3 clinical trial experience.
ā¢ Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
ā¢ Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
ā¢ Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
ā¢ Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
ā¢ R/SAS programming skills
ā¢ Demonstrated ability to work pro-actively and independently.
ā¢ Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
ā¢ Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
ā¢ Experience with CDISC, including SDTM, ADAM, CDASH
Nice-to-haves
ā¢ Leading DSBM or DMC for biostatistics
Benefits
ā¢ Home-based remote working opportunities.
ā¢ Work/life balance as well as flexible schedules.
ā¢ Collaborating with motivated, high-performance, statistical and research teams.
ā¢ Technical training and tailored development curriculum.
ā¢ Research opportunities that match your unique skillset.
ā¢ Promising career trajectory.
ā¢ Job stability: long-term engagements and re-deployment opportunities.
ā¢ Focus on bringing new therapies to market rather than project budgets and change orders.
ā¢ Experience with regulatory submissions.
ā¢ Engaging, fast-paced environment.
ā¢ Good work-life balance.
Apply tot his job
Apply To this Job