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in Cambridge, MA
Sr. Director, Statistical Innovation - Full-time / Part-time
•30 days ago
Hours | Full-time, Part-time |
---|---|
Location | Cambridge, Massachusetts |
About this job
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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