Senior Director, Biostatistics

About this role

<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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p> <p><span class="TextRun SCXW54249714 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW54249714 BCX8" 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, Biostatistics provides strategic, technical, and operational leadership for biostatistical activities across one or more clinical development programs. </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">As a senior statistical leader and cross-functional partner, this role</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body"> leads statistical activities across the drug development lifecycle, including protocol development, </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">authoring</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body"> of statistical sections of protocols, development of statistical analysis plans, oversight of statistical analyses and</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body"> deliverables</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">, interpretation and communication of clinical trial results, and preparation of clinical study reports, regulatory documents, manuscripts, and scientific presentations. </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">The Senior Director</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body"> provides statistical leadership for global regulatory submissions </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">and health authority interactions, </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">ensur</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">ing</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body"> that clinical development programs are supported by scientifically rigorous, operationally </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">feasible</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">, and innovative statistical strategies aligned with program and corporate </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">objectives</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">.</span> <span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">The role requires </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">strong communication</span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body"> skills, scientific leadership, self-motivation, and </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">a </span><span class="NormalTextRun SCXW54249714 BCX8" data-ccp-parastyle="Body">strategic and forward-thinking approach. Experience in rare disease drug development is desirable.</span></span><span class="EOP Selected SCXW54249714 BCX8" data-ccp-props="{}"> </span></p> <p>This role is based in Waltham, MA.</p> <p><strong>Primary Responsibilities Include:</strong></p> <ul> <li><span data-contrast="auto">Serve as the senior biostatistics lead and subject matter expert for assigned clinical studies, programs, and development initiatives</span><span…