Sr. Director, Statistical Innovation - Full-time / Part-time

Company: The Ascent Services Group, Inc
Location: Cambridge
Posted on: July 30, 2020

Job Description:

We're looking for a candidate to fill this position in anexciting company.

• Provide leadership on statistical innovation by directingand/or coordinating Biometrics efforts to identify and enableinnovative statistical design options and analyses that offer thepotential to accelerate clinical development programsefficiently
• Provide strategic input and technical guidance for clinicaldevelopment programs on innovative statistical methodologies,especially as they are applied to rare diseases
• Monitor advances in statistical methodologies throughliterature review, conference participation and interactions withexternal experts on statistical innovation
• Lead efforts on meta-analyses across clinical developmentprograms utilizing clinical study and natural history data to gaininsight on diseases, outcomes, study designs and analysismethodologies
• Conduct statistical modeling to enable robust and efficientstatistical designs and to address identified or potentialstatistical issues arising in clinical studies or programs
• Contribute to clinical protocol development where innovativestatistical designs or analyses are employed, includingauthoring/reviewing of the Statistics section and reviewing ofother relevant sections
• Author or oversee the development of statistical analysis plansfor meta-analyses, and oversee the development of shells fortables, figures and listings
• Provide statistical input to data monitoring committee (DMC)charters, independent review charters, and other study-leveldocuments where innovative statistical designs or analyses areemployed
• Address statistical questions/comments concerning theinnovative statistical approaches from the FDA and other regulatoryagencies, and review and address comments by IRB/ECs
• Lead or contribute to the preparation of publications,including manuscripts, posters and oral presentations
• Represent team regarding statistical issues in meetings withexternal parties including regulatory agencies and corporatepartners
• May lead or oversee projects that pilot or validate newassessments, or other projects that require innovation
• Manage at least one direct report and lead the statisticalinnovation team comprising of biostatisticians and statisticalprogrammers
• Ph.D. in statistics or related discipline with at least 10years of experience in the pharmaceutical or biotech industry
• Demonstrated expertise in innovative statistical methodologies,both frequentist and Bayesian approaches, especially as they areapplied to clinical development for small populations or rarediseases
• Experience of leading or managing a statistical team forclinical development program(s) or statistical innovation andconsultation
• Excellent computing, modelling and simulation skills using R,SAS, WinBugs, EAST, etc
• Experience in the design, analysis and reporting of clinicaltrials
• Experience in NDAs, MAAs or other regulatory submissions
• Knowledge of FDA, EMA and ICH regulations and guidelines
• Ability to concurrently lead or coordinate statistical effortsfor multiple projects
• Ability to effectively communicate statistical concepts in aclear and concise manner both written and verbally.

Keywords: The Ascent Services Group, Inc, Waltham , Sr. Director, Executive , Cambridge, Massachusetts

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