Associate Director, 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><strong><span data-contrast="auto">Position Title: </span></strong><span data-contrast="auto">Associate Director, 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><span data-contrast="auto">Job Overview</span></strong><span data-ccp-props="{}"> </span></p> <p>The Associate Director 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. 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 AD will play an important role in helping establish SOPs and programming standards and also build our SCE platform. </p> <p> </p> <p><strong><span data-contrast="auto">Essential Duties and Responsibilities</span></strong><span data-ccp-props="{}"> </span></p> <p><span data-ccp-props="{}"><strong>Key Project Responsibilities:</strong></span></p> <ul> <li><span data-ccp-props="{}">Provides programming leadership and Oversee compound-level programming deliverable in collaboration with the Stats lead and cross-functional teams.</span></li> <li><span data-ccp-props="{}">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.</span></li> <li><span data-ccp-props="{}">Lead programming team to produce and/or validate SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs, and ad-hoc analyses.</span></li> <li><span data-ccp-props="{}">Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.</span></li> <li><span data-ccp-props="{}">Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.</span></li> <li><span data-ccp-props="{}">Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.</span></li> <li><span data-ccp-props="{}">Develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming team.</span></li> <li><span data-ccp-props="{}">Develops robust program to create define.xml, Leads the NDA eSubmission package preparation.</span></li> <li><span data-ccp-props="{}">Assist Biometric in building the statistical computing environment (SCE) platform, including designing folder structure and managing access control.</span></li> </ul> <p><span data-ccp-props="{}"><strong>Initiative Responsibilities:</strong><br></span></p> <ul> <li><span data-ccp-props="{}">Under guidance from Head of Statistical Programming, implement innovative strategies and technologies to enhance programming processes. </span></li> <li><span data-ccp-props="{}">Working with manager, establish Statistical Programming standard and deploy programming strategies, specifications and programmed analysis.</span></li> <li>Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability. </li> </ul> <p><span data-ccp-props="{}"><strong>Managerial Responsibilities:</strong><br></span></p> <ul> <li><span data-ccp-props="{}">This position may manage direct reports as the programming team grows.</span></li> <li><span data-ccp-props="{}">In this role, AD is responsible for managing employees: set objectives, manage assignments and performance, and provide meaningful coaching and feedback.</span></li> <li><span data-ccp-props="{}">Support the evaluation and recruitment of potential employees.</span></li> <li><span data-ccp-props="{}">Manages junior programmers and internal contractors; provides mentorship.</span></li> </ul> <p> </p> <p><span data-ccp-props="{}"><strong><span data-contrast="auto">Qualifications and Preferred Skills</span></strong> </span></p> <ul> <li><span data-ccp-props="{}">Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.</span></li> <li><span data-ccp-props="{}">Minimum of 8 years statistical programming experience in the pharmaceutical, biotech or CRO clinical trial environment.</span></li> <li><span data-ccp-props="{}">Advanced SAS programming skills. Extensive Hands-on experience with SDTM, ADaM, TLF programming </span></li> <li><span data-ccp-props="{}">Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements.</span></li> <li><span data-ccp-props="{}">Good knowledge of drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology.</span></li> <li><span data-ccp-props="{}">Broad expertise in statistical programming and in developing computing strategies.</span></li> <li><span data-ccp-props="{}">In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.</span></li> <li><span data-ccp-props="{}">Demonstrated proficiency in using SAS/R to produce analysis datasets and TFLs.</span></li> <li><span data-ccp-props="{}">Knowledge of data validation, define.xml generation using Pinnacle 21.</span></li> <li><span data-ccp-props="{}">Results orientated with proven problem-solving skills and a strong interest in ongoing learning.</span></li> <li><span data-ccp-props="{}">Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams</span></li> <li><span data-ccp-props="{}">Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors.</span></li> <li><span data-ccp-props="{}">Adaptable and thrives in a fast-paced, startup environment while managing multiple priorities effectively.</span></li> <li><span data-ccp-props="{}">Experience with regulatory audits and inspections and IR (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.</span></li> </ul><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>$181,000</span><span class="divider">—</span><span>$250,000 USD</span></div></div></div>