Manager, Feasibility Analytics

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Overview

The Manager, Feasibility Analytics is responsible for developing thorough methods of data analysis for clinical trial feasibility insights, specific to indication, program, study, enrollment forecasting, country, and site feasibility across the Clinical Operations portfolio of clinical trials. He/she/they will partner within key stakeholders across the Feasibility Center of Excellence (CoE) to deliver feasibility analytics outputs used to derive optimized operational strategies.

He/she/they will provide impactful insights while ensuring patients and participants are at the center of decision making.

The Manager, Feasibility Analytics is an intelligent and effective data-driven leader focused on the acquisition of data, data engineering, algorithm development, automation, and technology solutions to improve clinical trial decision making. The role is responsible for creating the analytics infrastructure for the future and broadening data culture and literacy across the Clinical Development organization to ensure effective delivery of Alnylam’s portfolio of studies.

He/she/they will work cross functionally with Clinical Portfolio Systems (CPS) and Information Technology (IT) to ensure timely and thorough global (end to end) feasibility outputs that are then utilized by the Feasibility Strategists to apply and influence key trial and program stakeholders. Technologies and data outputs owned by the Feasibility CoE are likely to be utilized across Expertise Areas (EAs) in addition to Clinical Operations (Clin Ops).

He/she/they consistently delivers high quality outputs and service to fulfill the most impactful suite of feasibility deliverables. He/she/they derives and develops epidemiology, market research, competitive intelligence, past performance, country and site intelligence, expertise, and innovative data and AI methodologies to ultimately drive improved decision making for successful trial enrollment outcomes.

The Manager, Feasibility Analytics is responsible for ensuring precise, predictive, and applicable data and insights packages working closely with the Feasibility Strategists. He/she/they provides data-driven assessments of protocol do-ability, patient voice, site and patient burden, study, country and site enrollment scenarios, country and site selection, and risk mitigation strategies to drive predictable and accelerated study execution of global clinical trials. This role works closely with other analytics colleagues and functions globally, both internal and external to Alnylam.

Key Responsibilities

• Creates and delivers consistent feasibility data analytics packages; inclusive of, but not limited to, historical / current clinical trials, epidemiology, standard of care, enrollment rates, start up timelines, enrollment forecasts, patient and site burden scores, site lists, site performance prediction, etc.
• Ensures on-time and high-quality of deliverables, specific to each stakeholder’s perspectives and needs.
• Routinely monitors enrollment and start up to indicate if clinical trials are performing to plan and then signaling when indicator thresholds are surpassed.
• Partners with stakeholders, CROs, and vendors to capitalize on historic study/site performance data, competitor trial performance, industry benchmarks, epidemiology, etc. using a variety of analytics and modeling tools to drive baseline study milestones targets/dates (CLOCK).
• Provides internal benchmarking and early forecasting to ensure proposed timelines and committed milestones are accurate and achievable.
• Drives improved KPI/metrics and intelligence to support process improvement and overall operational/business reporting.
• Provides improvements to feasibility data and analytics to improve the data infrastructure and usability of data to optimize clinical trials.
• In conjunction with Feasibility Strategists, derives impactful insights from data analyses.
• Optimizes operational delivery considering time, cost, quality, and burden and supports the data and outputs needed to baseline (CLOCK) the study assumptions.
• Effectively listens to stakeholders to understand problem statements and ascertain data to answer key questions for trial optimization.
• Continually improves the overall feasibility strategy and process to be flexible, yet systematic across the pipeline.
• Drives a patient-and-site-first mindset throughout the organization to create more successful, inclusive, and optimized clinical trials.

Qualifications

• University Degree in Science, Computer Science, Informatics, or related discipline. A higher degree is desirable.
• Intermediate (2+ years) previous experience gained with a CRO or biopharmaceutical company working on…