Associate Director/Sr. Manager, Statistical Innovation, Biostatistics

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POST DATE 12/12/2019
END DATE 12/13/2019

Sarepta Therapeutics Cambridge, MA

Location
Cambridge, MA
AJE Ref #
585831906
Job Classification
Full Time
Job Type
Regular
Company Ref #
4275153002
Experience
Mid-Career (2 - 15 years)

JOB DESCRIPTION

The incumbent will be a member of the Statistical Innoation team, and will provide expertise on statistical innovation to advise clinical development teams on complex and/or innovative designs and analyses, as they are applicable to rare diseases. The ideal candidate is a good communicator, innovative, high-energy, self-motivated, and forward thinking. Experience working in rare disease is desirable, but not required.

Primary responsibilities:

* Serve as a biostatistics expert or point of contact for assigned projects

* Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables

* Identify and enable innovative statistical design and analyses to accelerate clinical development programs

* Provide technical guidance for clinical development programs on innovative statistical methodologies

* Monitor advances in statistical methodologies through literature review, conference participation and interactions with external experts on statistical innovation

* Conduct meta-analyses across clinical development programs utilizing clinical study data and potentially external control data

* Conduct statistical modeling/simulation to enable robust and efficient statistical designs and to address statistical issues in clinical studies or programs as they arise

* Contribute to clinical protocol development where innovative statistical designs or analyses are employed, including authoring/reviewing of the Statistics section and reviewing of other relevant sections

* Author or oversee the development of statistical analysis plans for meta-analyses

* Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents where innovative statistical designs or analyses are employed

* Review and address statistical questions/comments from regulatory agencies and IRB/ECs concerning the innovative statistical approaches

* Contribute to the preparation of publications, including manuscripts, posters and oral presentations

* Validate the results of key statistical deliverables

* Perform ad hoc and exploratory statistical analyses as needed

Education and Skills Requirements:

* Ph. D. in Statistics or related discipline

* At least three years of experience in the pharmaceutical or biotech industry for Sr. Manager level, and at least five years of experience in the pharmaceutical or biotech industry for Associate Director

* Demonstrated expertise in innovative statistical methodologies, both frequentist and Bayesian approaches, especially as they are applied to clinical development for small populations or rare diseases

* Experience in the design, analysis and reporting of clinical trials; experience designing and conducting adaptive trials is a plus, but not required

* Excellent computing, programming, modelling and simulation skills using R, SAS, WinBugs, etc

* Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner

* Working knowledge of FDA, EMA and ICH regulations and guidelines

* Experience in NDAs, MAAs or other regulatory submissions is a plus, but not required

* Demonstrated positive attitude and the ability to work well with others

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.