Senior Manager, Statistical Programming

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}"> </span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div> </div> <div>Led by Tassos Giannakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.</div> <div> </div> <div>We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.</div> <div> </div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div> </div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div> </div> <div> </div></div><p></p> <p><strong><span data-contrast="auto">Position Title: </span></strong><span data-contrast="auto">Senior Manager, Statistical Programming</span></p> <p><strong><span data-contrast="auto">Department: </span></strong><span data-contrast="auto">Clinical Data Sciences & Analytics</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Reports To:</span></strong><span data-contrast="auto"> Head of Statistical Programming</span></p> <p><strong><span data-contrast="none">Location: </span></strong><span data-contrast="none">South San Francisco, CA or </span><span data-contrast="none">Princeton, NJ – On-site 4 days per week (Mon to Thurs)</span><span data-ccp-props="{}"> </span></p> <p> </p> <p><strong>Job Overview:</strong></p> <p>The Senior Manager of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks.</p> <p>This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this position will play an important role in helping establish SOPs and programming standards and also build our SCE platform.</p> <p> </p> <p><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES</strong></p> <p><strong>Key Project Responsibilities:</strong></p> <ul> <li>Provides programming leadership and oversee study to compound-level programming deliverable in collaboration with the Stats lead and cross-functional teams.</li> <li>Serve as the lead programmer to reviews SAP, Data Presentation Plan, Table Shell to align with project objectives and ensures clarity and completeness of programming assumptions and requirements.</li> <li>Lead programming team to produce and/or validate SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs, and ad-hoc analyses.</li> <li>Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.</li> <li>Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.</li> <li>Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.</li> <li>Develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming team.</li> <li>Develops robust program to create define.xml, Leads the NDA eSubmission package preparation.</li> <li>Assist Biometric in building the statistical computing environment (SCE) platform, including designing folder structure and managing access control.</li> </ul> <p> </p> <p><strong>Initiative Responsibilities:</strong></p> <ul> <li>Under guidance from Head of Statistical Programming and Compound PL, implement innovative strategies and technologies to enhance programming processes.</li> <li>Working with manager, establish Statistical Programming standard and deploy programming strategies, specifications and programmed analysis.</li> <li>Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability.</li> </ul> <p> </p> <p><strong>Qualifications and Preferred Skills</strong></p> <p><strong>Education:</strong></p> <ul> <li>Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.</li> </ul> <p><strong>Experience and Skill Set:</strong></p> <ul> <li>Minimum of 6 years statistical programming experience in the pharmaceutical, biotech or CRO clinical trial environment.</li> <li>Advanced SAS programming skills. Extensive Hands-on experience with SDTM, ADaM, TLF programming</li> <li>Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements.</li> <li>Good knowledge of drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology.</li> <li>Broad expertise in statistical programming and in developing computing strategies.</li> <li>In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.</li> <li>Demonstrated proficiency in using SAS/R to produce analysis datasets and TFLs.</li> <li>Knowledge of data validation, define.xml generation using Pinnacle 21.</li> <li>Results orientated with proven problem-solving skills and a strong interest in ongoing learning.</li> <li>Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams</li> <li>Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors.</li> <li>Adaptable and thrives in a fast-paced, startup environment while managing multiple priorities effectively.</li> <li>Experience with regulatory audits and inspections and IR (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.</li> </ul> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$172,000</span><span class="divider">—</span><span>$234,000 USD</span></div></div></div>