Associate Director
Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020
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Job Description:
Associate Director/Sr. Manager, Statistical Innovation,
Biostatistics Company: HCPro, Inc. Location: Cambridge Posted on: September 12, 2020 Job Description: Associate Director/Sr. Manager, Statistical
Innovation,Biostatistics Associate Director/Sr. Manager, Statistical
Innovation,Biostatistics The incumbent will be a member of the
StatisticalInnovation team, and will provide expertise on
statisticalinnovation to advise clinical development teams on
complex and/orinnovative designs and analyses, as they are
applicable to rarediseases. The ideal candidate is a good
communicator, innovative,high-energy, self-motivated, and
forward?thinking. Experienceworking in rare disease is desirable,
but not required. Primary responsibilities: Serve as a biostatistics expert or point of contact for
assignedprojects Work collaboratively with internal and external (e.g., CRO)
teammembers to coordinate the planning and execution of
statisticaldeliverables Identify and enable innovative statistical design and analysesto
accelerate clinical development programs Provide technical guidance for clinical development programs
oninnovative statistical methodologies Monitor advances in statistical methodologies through
literaturereview, conference participation and interactions with
externalexperts on statistical innovation Conduct meta-analyses across clinical development
programsutilizing clinical study data and potentially external
controldata Conduct statistical modeling/simulation to enable robust
andefficient statistical designs and to address statistical issues
inclinical studies or programs as they arise 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 Provide statistical input to data monitoring committee
(DMC)charters, independent review charters, and other
study-leveldocuments where innovative statistical designs or
analyses areemployed Review and address statistical questions/comments fromregulatory
agencies and IRB/ECs concerning the innovativestatistical
approaches Contribute to the preparation of publications,
includingmanuscripts, posters and oral presentations Validate the results of key statistical deliverables Perform ad hoc and exploratory statistical analyses asneeded Education and Skills Requirements: Ph.D. in Statistics or related discipline At least three years of experience in the pharmaceutical
orbiotech industry for Sr. Manager level, and at least five years
ofexperience in the pharmaceutical or biotech industry for
AssociateDirector Demonstrated expertise in innovative statistical
methodologies,both frequentist and Bayesian approaches, especially
as they areapplied to clinical development for small populations or
rarediseases Experience in the design, analysis and reporting of
clinicaltrials; experience designing and conducting adaptive trials
is aplus, but not required Excellent computing, programming, modelling and simulationskills
using R, SAS, WinBugs, etc Excellent written and oral communication skills, including
theability to effectively communicate statistical concepts in a
clearand concise manner Working knowledge of FDA, EMA and ICH regulations
andguidelines Experience in NDAs, MAAs or other regulatory submissions is
aplus, but not required Demonstrated positive attitude and the ability to work well
withothers Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation
andbenefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative
Actionemployer and participates in e-Verify. Job Information Job ID: 53698895 Location: Cambridge, Massachusetts, United States Sarepta Therapeutics, headquartered in Cambridge,
Massachusetts,is a commercial-stage biopharmaceutical company
focused on thediscovery and development of unique RNA-targeted
therapeutics forthe treatment of rare neuromuscular diseases. The
Company isprimarily focused on rapidly advancing the development of
itspotentially disease-modifying DMD drug candidates. For
moreinformation, please visit us at www.sarepta.com. Cambridge, Massachusetts, United States Associate Director, Research & Clinical Development
QualityAssurance Senior Manager, Scientific Communications and... bluebird bio Cambridge, Massachusetts, United States Medical Writer bluebird bio Cambridge, Massachusetts, United States Technical Associate I - Page Lab Whitehead Institute for... Cambridge, Massachusetts, United States 100 Winners Circle, Suite 300 Brentwood, Tennessee 37027
(978)624-4594 Keywords: HCPro, Inc., Cambridge , Associate Director/Sr.
Manager, Statistical Innovation, Biostatistics, Other , Cambridge,
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