Director, Biostatistics Position Available In Middlesex, Massachusetts

Job Description:

Company Overview:

Dyne Therapeutics is discovering and advancinginnovative life-transforming therapeutics for people living withgenetically driven neuromuscular diseases. Leveraging themodularity of its FORCE™ platform, Dyne is developing targetedtherapeutics that deliver to muscle and the central nervous system(CNS). Dyne has a broad pipeline for neuromuscular diseases,including clinical programs for myotonic dystrophy type 1 (DM1) andDuchenne muscular dystrophy (DMD) and preclinical programs forfacioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary:

The Director, Biostatistics will provide leadershipand guidance for assigned clinical studies within a clinicaldevelopment program(s). This person will be responsible forstatistical activities including: designing innovative clinicaltrials, authoring statistical sections of protocols, preparingstatistical analysis plans, ensuring quality in implementation ofstatistical analysis, interpreting and communicating the results ofstatistical analysis of clinical trial data in support ofregulatory submissions as well as manuscripts. The ideal candidatemust be a good communicator, exhibit high-energy, self-motivation,and forward-thinking. Experience working in rare disease isdesirable. This role is based in Waltham, MA with hybrid workflexibility.

Primary Responsibilities Include:

Serve as abiostatistics lead for assigned clinical studies, (orcompound-level activities as required) Effectively interact withmembers in other functions including medical, regulatory, safety,clinical operations and translational medicine for planning toensure optimized delivery of clinical study activities Workcollaboratively with internal and external (e.g., CRO) team membersto coordinate the planning and execution of statisticaldeliverables Contribute to clinical protocol development, includingauthoring of the Statistics section and reviewing of other sectionsby applying statistical principles Design and specifystratification /randomization schema; review and approve testrandomization lists Collaborate with Data Management, ClinicalDevelopment and Clinical Operations on design and review of eCRFs,and ensure data collection meet the requirements of statisticalanalyses Author or contribute to the development of statisticalanalysis plans for clinical trials and for integrated summaries ofsafety/effectiveness (ISS/ISE) as necessary, Provide guidance tostatistical programmers on SDTM/ADaM and draft (or oversee) thedevelopment of shells for tables, figures and listings (TFLs)Provide statistical input to data monitoring committee (DMC)charters, independent review charters, and other study-leveldocuments Provide statistical review of statistical deliverables(e.g ADaM datasets, TFLs) Contributes to clinical study reports andother regulatory documents as required e.g. DSURs, BriefingDocuments, etc. Perform ad hoc and exploratory statistical analysesas needed Assist in assigned statistical activities in support ofIND/NDA/MAA or other regulatory submissions Assist in addressingstatistical questions/comments from FDA and other regulatoryagencies, and review and address comments by IRB/ECs Support andcontribute to the preparation of publications, includingmanuscripts, posters and oral presentations Identify and implementemerging new ways of doing clinical development and newmethodologies Contribute to standardization and process improvementefforts for Biostatistics function and contribute tocross-functional process improvement efforts

Education and SkillsRequirements:

Ph.D. (or Masters) in statistics or Biostatistics orequivalent with at least 10 years of experience in thepharmaceutical or biotech industry desired Interest in and basicunderstanding of biology and biological process including ASO andsiRNA Demonstrated ability and experience in the design, analysisand reporting of clinical trials Experience in NDAs, MAAs or otherregulatory submissions desirable In-depth knowledge of statisticalmethods for clinical trials, including both frequentist andBayesian approaches Knowledge of FDA, EMA and ICH regulations andguidelines Proficient in statistical programming (SAS is requiredand R is a plus) Experience with trial design software (e.g., EAST)Ability to concurrently lead statistical efforts for multiplestudies Understanding of data standards, including SDTM and ADaMAdept at overseeing statistical services provided by CRO’s and/orcontractors Ability to work independently and act with initiativeto address issues Ability to effectively communicate statisticalconcepts in a clear and concise manner both written and verbally.

The statements contained herein reflect general details asnecessary to describe the principles functions for this job, thelevel of knowledge and skill typically required, and the scope ofresponsibility, but should not be considered an all-inclusivelisting of work requirements. Individuals may perform other dutiesas assigned, including work in other functional areas to coverabsences or relief, to equalize peak work periods or otherwisebalance workload. This description is not intended to beconstructed as an exhaustive list of duties, responsibilities, orrequirements for the position. This position may change or assumeadditional duties at any time. The employee may be requested toperform different or additional duties as assigned. All Employeesare expected to adhere to all company policies and act as a rolemodel for company values. Dyne Therapeutics is an equal opportunityemployer and will not discriminate against any employee orapplicant on the basis of age, color, disability, gender, nationalorigin, race, religion, sexual orientation, veteran status, or anyclassification protected by federal, state, or local law.