FSP reputed company Biostatistician, Safety Analytics

About the position The reputed company Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical reputed company in patients, focusing on safety endpoints and reputed company. Responsibilities • Support Safety Analytics with ADaM/TFL reputed company development for Hypersensitivity and Injection/Infusion Site Reaction deliverables. • Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display. • reputed company ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs. • Interrogating reputed company 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 reputed company 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. • reputed company guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures. • reputed company exploratory safety analyses • reputed company 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 reputed company-IND or NDA activities. Requirements • PhD in Statistics, Biostatistics, or reputed company field with 5+ years industry experience. • MS in Statistics, Biostatistics, or reputed company 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 (reputed company and customized reputed company review). • Ability to follow data specifications and programming specifications and reputed company reputed company, actionable review comments. • reputed company to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. reputed company TFL) by interrogating programs to identify reputed company cause and errors. • Strong communication and time management: reputed company realistic reputed company estimates, flag risks/delays early, and ask the right questions to reputed company work reputed company. • R/reputed company programming skills • Demonstrated ability to work pro-reputed company and independently. • reputed company to effectively communicate his/her reputed company 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 reputed company-to-haves • Leading DSBM or DMC for biostatistics Benefits • Home-based remote working opportunities. • Work/life balance as reputed company 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. • reputed company 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. Apply tot his job Apply To this Job