Associate Director, Biostatistics
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 genetic 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 Include:
Works collaboratively with internal and external (e.
g.
, CRO) team members to coordinate the planning and execution of statistical deliverablesConducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programsContributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principlesAuthors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listingsReviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analysesDesigns and specifies randomization schedules; reviews and approves test randomization listsProvides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documentsReviews analysis dataset specificationsPerforms QC/QA of statistical deliverables including validation of key analysis resultsPerforms ad hoc and exploratory statistical analyses as neededContributes to clinical study reports, including authoring of statistical methods and interpretation of the study resultsBe responsible for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissionsAddresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECsSupports and contributes to the preparation of publications, including manuscripts, posters and oral presentationsContributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement effortsDesired Education and Skills:
Ph.
D.
in Statistics or related disciplineAt least five years of experience in the pharmaceutical or biotech industry for Associate Director; at least three years of experience in the pharmaceutical or biotech industry for Sr.
Manager levelDemonstrated ability and experience in the design, analysis and reporting of clinical trialsExperience in NDAs, MAAs, or other regulatory submissions desirable, but not requiredIn-depth knowledge of statistical methods for clinical trialsWorking knowledge of FDA, EMA and ICH regulations and guidelinesProficient in statistical programming in SAS and RProficient in statistical design software such as EASTAbility to concurrently work on multiple studiesUnderstanding of data standards, including SDTM and ADaMAbility to oversee statistical services provided by CRO's and/or contractorsAbility to collaborate effectively with colleagues from other functionsExcellent written and oral communication skills#LI-RemoteThis position is remote.
However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $156,000 - $195,000 per year.
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
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.
SummaryLocation:
Cambridge, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
It is an excellent opportunity to work at the forefront of precision genetic 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 Include:
Works collaboratively with internal and external (e.
g.
, CRO) team members to coordinate the planning and execution of statistical deliverablesConducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programsContributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principlesAuthors or reviews statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and authors or oversees the development of shells for tables, figures and listingsReviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analysesDesigns and specifies randomization schedules; reviews and approves test randomization listsProvides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documentsReviews analysis dataset specificationsPerforms QC/QA of statistical deliverables including validation of key analysis resultsPerforms ad hoc and exploratory statistical analyses as neededContributes to clinical study reports, including authoring of statistical methods and interpretation of the study resultsBe responsible for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissionsAddresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECsSupports and contributes to the preparation of publications, including manuscripts, posters and oral presentationsContributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement effortsDesired Education and Skills:
Ph.
D.
in Statistics or related disciplineAt least five years of experience in the pharmaceutical or biotech industry for Associate Director; at least three years of experience in the pharmaceutical or biotech industry for Sr.
Manager levelDemonstrated ability and experience in the design, analysis and reporting of clinical trialsExperience in NDAs, MAAs, or other regulatory submissions desirable, but not requiredIn-depth knowledge of statistical methods for clinical trialsWorking knowledge of FDA, EMA and ICH regulations and guidelinesProficient in statistical programming in SAS and RProficient in statistical design software such as EASTAbility to concurrently work on multiple studiesUnderstanding of data standards, including SDTM and ADaMAbility to oversee statistical services provided by CRO's and/or contractorsAbility to collaborate effectively with colleagues from other functionsExcellent written and oral communication skills#LI-RemoteThis position is remote.
However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $156,000 - $195,000 per year.
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
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.
SummaryLocation:
Cambridge, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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