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Associate Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

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

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100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978)624-4594

Keywords: HCPro, Inc., Cambridge , Associate Director/Sr. Manager, Statistical Innovation, Biostatistics, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director, Other , Cambridge, Massachusetts

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