Associate Director, Biostatistics
Company: Sarepta Therapeutics
Location: Somerville
Posted on: January 14, 2021
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Job Description:
The person in this position will be working with a
cross---functional team as the project biostatistician responsible
for statistical activities at the compound level or study level for
one or more gene therapy programs. It is an excellent opportunity
to work at the forefront of precision medicine, making an impact to
the development of transformative therapies that may change the
lives of patients. The ideal candidate is a good communicator,
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 clinical studies or compound-level
activitiesWork collaboratively with internal and external (e.g.,
CRO) team members to coordinate the planning and execution of
statistical deliverablesConduct statistical modeling to enable
robust and efficient statistical designs and to address identified
or potential statistical issues arising in studies or
programsContribute to clinical protocol development, including
authoring of the Statistics section and reviewing of other sections
by applying statistical principlesAuthor or review the development
of statistical analysis plans for clinical trials and for
integrated summaries of safety/effectiveness (ISS/ISE), and author
or oversee the development of shells for tables, figures and
listingsReview case report form (CRF) designs to ensure data
collection meet the requirements of statistical analysesDesign and
specify randomization schedules; review and approve test
randomization listsProvide statistical input to data monitoring
committee (DMC) charters, independent review charters, and other
study-level documentsPerform QC/QA of statistical deliverables
including validation of key analysis resultsPerform ad hoc and
exploratory statistical analyses as neededContribute to clinical
study reports, including authoring of statistical methods and
interpretation of the study resultsBe accountable for assigned
statistical activities in support of IND/NDA/MAA or other
regulatory submissionsAddress statistical questions/comments from
FDA and other regulatory agencies, and review and address comments
by IRB/ECsSupport and contribute to the preparation of
publications, including manuscripts, posters and oral
presentationsContribute or lead standardization and process
improvement efforts for Biometrics and contribute to
cross-functional process improvement effortsRepresent Sarepta
regarding statistical issues in meetings with external parties
including regulatory agencies and corporate partnersEducation and
Skills Requirements: Ph.D. in statistics or related disciplineAt
least five years of experience in the pharmaceutical or biotech
industryDemonstrated ability and experience in the design, analysis
and reporting of clinical trialsExperience in NDAs, MAAs, J-NDA, or
other regulatory submissions desirable, but not requiredIn-depth
knowledge of statistical methods for clinical trials, including
Bayesian approachesKnowledge of FDA, EMA and ICH regulations and
guidelinesProficient in statistical programming (SAS and
R)Experience with trial design software (e.g., EAST)Ability to
concurrently take on multiple activitiesUnderstanding of data
standards, including SDTM and ADaMAdept at overseeing statistical
services provided by CRO---s and/or contractorsAbility to work
independently and act with initiative to address issuesAbility to
collaborate effectively with colleagues from all functionsExcellent
written and oral communication skills, including the ability to
effectively communicate statistical concepts in a clear and concise
manner.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.Full time
Keywords: Sarepta Therapeutics, Somerville , Associate Director, Biostatistics, Executive , Somerville, Massachusetts
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