Senior Director, Medical Affairs Biostatistics
Dyne Therapeutics · Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
$265K–$300KWaltham, MA101-250 employeesPosted 15 days ago
Post-IPO Equity · $375Mraised 3 months agoled by Franklin Templeton, RA Capital Management, Wellington Management
This board only lists companies whose most recent round closed in the last 180 days.
<div class="content-intro"><h3>Company Overview:</h3>
<p>Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0">https://www.dyne-tx.com/</a>, and follow us on <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0">X</a>, <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0">LinkedIn</a> and <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="none"><span data-ccp-parastyle="Body" data-ccp-parastyle-defn="{"ObjectId":"b669530d-9cee-5fd4-8da3-4cdbed7bfaa2|1","ClassId":1073872969,"Properties":[469775450,"Body",201340122,"2",134233614,"true",469778129,"Body",335572020,"1",469777841,"Helvetica",469777842,"Helvetica",469777843,"Helvetica",469777844,"Helvetica",469769226,"Helvetica",335551500,"0",268442635,"22"]}">The Senior Director, Medical Affairs Biostatistics provides strategic, technical, and operational leadership for biostatistics across Medical Affairs evidence</span><span data-ccp-parastyle="Body">-</span><span data-ccp-parastyle="Body">generation</span> <span data-ccp-parastyle="Body">activities. This</span><span data-ccp-parastyle="Body"> role serves as the primary statistical partner to Medical Affairs leadership and </span><span data-ccp-parastyle="Body">is accountable</span><span data-ccp-parastyle="Body"> for </span><span data-ccp-parastyle="Body">shaping statistically rigorous, fit-for-purpose evidence strategies that support scientific </span><span data-ccp-parastyle="Body">communication</span><span data-ccp-parastyle="Body">, external engagement, payer and access needs, and</span> <span data-ccp-parastyle="Body">lifecycle</span><span data-ccp-parastyle="Body"> planning.</span> <span data-ccp-parastyle="Body">Areas</span><span data-ccp-parastyle="Body"> of responsibility include Phase IV studies, real-world evidence, observational re</span><span data-ccp-parastyle="Body">search, secondary and exploratory analyses of clinical development data, investigator-sponsored research,</span> <span data-ccp-parastyle="Body">clinical outcomes assessment (PRO/HRQoL)</span><span data-ccp-parastyle="Body">,</span> <span data-ccp-parastyle="Body">HEOR and value evidence activities, </span><span data-ccp-parastyle="Body">scientific publications, </span><span data-ccp-parastyle="Body">congress presentations, </span><span data-ccp-parastyle="Body">and other Medical Affairs </span><span data-ccp-parastyle="Body">evidence-generation </span><span data-ccp-parastyle="Body">initiatives</span><span data-ccp-parastyle="Body">.</span><span data-ccp-parastyle="Body"> The role requires </span><span data-ccp-parastyle="Body">the ability to </span><span data-ccp-parastyle="Body">operate</span><span data-ccp-parastyle="Body"> with </span><span data-ccp-parastyle="Body">a </span><span data-ccp-parastyle="Body">high degree of independence, influence cross-functional and senior stakeholders, translate complex statistical concepts into actionable insights, and build scalable processes, standards, and capabilities.</span><span data-ccp-parastyle="Body"> Experience in rare disease drug development</span><span data-ccp-parastyle="Body">, preferably neuromuscular disease, is preferred</span><span data-ccp-parastyle="Body">.</span></span><span data-ccp-props="{}"> </span></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="none"><span data-ccp-parastyle="Body">This role is based in Waltham, MA.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong>Primary Responsibilities Include:</strong></p>
<p><em><span data-contrast="none"><span data-ccp-parastyle="Body" data-ccp-parastyle-defn="{"ObjectId":"b669530d-9cee-5fd4-8da3-4cdbed7bfaa2|1","ClassId":1073872969,"Properties":[469775450,"Body",201340122,"2",134233614,"true",469778129,"Body",335572020,"1",469777841,"Helvetica",469777842,"Helvetica",469777843,"Helvetica",469777844,"Helvetica",469769226,"Helvetica",335551500,"0",268442635,"22"]}">Strategic Leadership and Evidence Planning</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></em></p>
<ul>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Serve as the senior Biostatistics lead and subject matter expert for Medical Affairs, providing strategic direction, independent statistical judgment, and hands-on statistical leadership</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Shape integrated evidence-generation strategies and product-level evidence plans in partnership with Medical Affairs, Clinical Development, HEOR, Value & Access, Regulatory, and Commercial stakeholders</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Represent Biostatistics on cross-functional Medical Affairs and evidence-generation teams, influencing strategic decisions and ensuring statistical approaches are scientifically rigorous, practical, and aligned with business and patient needs</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
</ul>
<p><em><span data-contrast="none"><span data-ccp-parastyle="Body">Study Design, Analysis, and Evidence Generation</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></em></p>
<ul>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead statistical strategy, study design, </span><span data-ccp-parastyle="Body">methodology</span><span data-ccp-parastyle="Body">, and execution for Phase IV, observational, registry, and real-world evidence studies</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead secondary, exploratory, and post hoc analyses of clinical development data to support Medical Affairs strategy, scientific exchange, publications, congress presentations, payer evidence, and lifecycle planning</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Provide statistical </span><span data-ccp-parastyle="Body">expertise</span><span data-ccp-parastyle="Body"> to HEOR, Value & Access, HTA, and payer-related activities, including methods for evidence generation, interpretation, and communication to external stakeholders</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Provide statistical leadership for clinical outcomes assessment, including PRO/HRQoL analysis, psychometric evaluation, score derivation, endpoint interpretation, and evidence to support publications, payer dossiers, and potential label-enabling activities</span></span> </li>
</ul>
<p><em><span data-contrast="none"><span data-ccp-parastyle="Body">Scientific Communication and Cross-Functional Partnership</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></em></p>
<ul>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Lead the statistical strategy for Medical Affairs publications and scientific communications, including manuscripts, abstracts, congress presentations, advisory boards, investigator-sponsored research, and external scientific collaborations</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Partner with Clinical Development Biostatistics to </span><span data-ccp-parastyle="Body">leverage</span><span data-ccp-parastyle="Body"> complementary </span><span data-ccp-parastyle="Body">expertise</span><span data-ccp-parastyle="Body">, ensure consistency across the product lifecycle, and </span><span data-ccp-parastyle="Body">maintain</span><span data-ccp-parastyle="Body"> alignment between development, regulatory, and Medical Affairs analyses</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Analyze, interpret, and communicate complex results to cross-functional teams, senior leadership, external collaborators, and non-technical audiences in a clear and actionable manner</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
</ul>
<p><em><span data-contrast="none"><span data-ccp-parastyle="Body">Operational Excellence and Vendor Oversight</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></em></p>
<ul>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Develop, review, and execute analysis plans, supplemental statistical analysis plans, table/listing/figure shells, dataset specifications, and associated documentation to ensure high-quality, inspection-ready statistical deliverables</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Partner closely with Data Management, Statistical Programming, Clinical Operations, and external vendors to ensure fit-for-purpose data, efficient study execution, and high-quality, </span><span data-ccp-parastyle="Body">timely</span><span data-ccp-parastyle="Body"> statistical deliverables supporting Medical Affairs studies and evidence-generation initiatives</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Provide oversight of CROs, consultants, and external vendors, including scope, quality, timelines, resourcing, issue escalation, and delivery of statistical services</span></span></li>
</ul>
<p><em><span data-contrast="none"><span data-ccp-parastyle="Body">Functional Leadership and Team Development</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></em></p>
<ul>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Drive standardization, process improvement, templates, best practices, and functional standards within Biostatistics and across cross-functional teams</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="Body">Manage, mentor, and develop direct reports and other statistical colleagues through direct management, matrix leadership, and technical mentorship, fostering technical excellence, collaboration, accountability, and a high-performing team environment</span></span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":278}"> </span></li>
</ul>
<p><strong>Education and Skills Requirements:</strong></p>
<ul>
<li><span data-contrast="none">PhD in Statistics, Biostatistics, or a related quantitative discipline with 10+ years of relevant pharmaceutical, biotechnology, or health-related industry experience; or MS with 12+ years of relevant experience</span><span data-ccp-props="{"335557856":16777215,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="none">Demonstrated experience leading the design, analysis, interpretation, and reporting of analyses within Medical Affairs, including Phase IV, observational, registry, and real-world evidence studies</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Experience supporting scientific publications, congress presentations, investigator-sponsored research, and external scientific engagement, including collaboration with investigators and presentation of statistical findings</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Strong expertise in statistical methodology relevant to observational and real-world research, including study design, bias and confounding, causal inference, longitudinal analysis, missing data, endpoint strategy, and time-to-event methods</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Advanced SAS programming skills are required; experience with R and familiarity with contemporary tools and approaches for real-world data analysis are preferred. Ability to perform, review, and oversee statistical analyses</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Experience overseeing CROs, consultants, and external vendors, including scope management, quality oversight, timelines, and deliverables</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Demonstrated experience leading and developing statisticians through direct management, matrix leadership, technical mentorship, or functional capability-building</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Ability to independently prioritize and manage multiple concurrent priorities and deliverables in a fast-paced, matrixed biotechnology environment</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Strong analytical judgment and problem-solving skills, with the ability to work through ambiguity, anticipate risks, and recommend practical, scientifically sound solutions</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Excellent verbal and written communication skills, with the ability to effectively communicate complex statistical concepts to technical and non-technical audiences, including senior leaders and external stakeholders</span><span data-ccp-props="{"335557856":16579836}"> </span></li>
<li><span data-contrast="none">Experience in rare disease, preferably neuromuscular disease, is preferred</span><span data-ccp-props="{"335557856":16777215,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="none">Interest in and basic understanding of biology and biological processes, including ASO and siRNA modalities</span><span data-ccp-props="{"335557856":16777215,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
</ul>
<p> </p>
<p>#LI-Onsite</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$265,000</span><span class="divider">—</span><span>$300,000 USD</span></div></div></div><div class="content-conclusion"><p> </p>
<p>The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.</p>
<p>The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.</p>
<p class="Body"><em><span style="font-family: 'Arial',sans-serif; color: #626262;">Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.</span></em></p></div>
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