{"id":3624524,"url":"https://alion.io/job/kardigan-associate-director-statistical-programming","title":"Associate Director, Statistical Programming","company":{"id":1889154,"name":"Kardigan","domain":"kardigan.bio","url":"https://alion.io/company/kardigan-bio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States","Princeton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":183000,"max":250000,"currency":"USD","period":"year","gross":null,"usd_annual":250000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CDISC","optional":false},{"name":"Git","optional":false},{"name":"SAS","optional":false},{"name":"Shiny","optional":false},{"name":"R","optional":true}],"status":"live","first_seen_at":"2026-11-02T17:04:39Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-03T18:37:13Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About Us \nKardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.\nIt is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.\nLed by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D.,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.\nWe 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.\nAt Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic -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 eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.\nThese values are the foundation of our work, empowering us to make a real difference, every day.\nDepartment: Clinical Data Sciences & Analytics \nReports To: Head of Statistical Programming \nLocation: South San Francisco, CA or Princeton, NJ - On-site 4 days per week (Mon to Thurs) \nJob Overview: \nThe Associate Director of Statistical Programming will serve as the compound lead, responsible for programming strategy and delivery across all studies and integrated analyses for an assigned compound. This role will lead internal and outsourced programming activities, ensuring quality, consistency, and timely delivery of clinical reporting and regulatory submission deliverables, while remaining hands-on in SAS/R programming and technical review. \nThis position will serve as the primary Statistical Programming representative on compound teams, partnering with Biostatistics and Clinical Data Management (CDM) to align data collection, analysis requirements, and programming plans. The compound lead will establish consistent programming standards across studies, coordinate resources and timelines, and proactively address delivery risks. Additionally, this position will contribute to establishing SOPs and programming standards and modernizing statistical reporting with open-source tools. \nESSENTIAL DUTIES AND RESPONSIBILITIES \nKey Project Responsibilities: \nServe as the compound programming lead, accountable for study- and compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams. \nDevelop and maintain programming plans, coordinate timelines and resource needs across studies, and proactively address delivery risks, escalating resource constraints and unresolved issues to the Head of Statistical Programming. \nLead programming review of SAPs, Data Presentation Plans, and Table Shells across the compound to align with development objectives and ensure clarity, consistency, and completeness of programming assumptions and requirements. \nLead the programming team to produce and/or validate SDTM, ADaM, and TLF deliverables across studies and integrated analyses for CSRs, regulatory requests, publication needs, and ad hoc analyses, remaining hands-on for complex programming and technical review. \nManage CROs and contractors supporting the compound, defining scope and acceptance criteria and ensuring compliance, quality of deliverables, and timelines. \nCollaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications, establishing consistent data standards and derivation conventions across studies to support compound-level analyses. \nWork closely with Data Management and Biostatistics teams to ensure database-lock readiness and the accuracy and traceability of final datasets, analyses, and reports across the compound. \nDevelop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team. \nOversee the development and validation of define.xml and supporting reviewer guides. Lead preparation of the compound’s programming deliverables for NDA eSubmissions, including integrated analyses, and coordinate programming support for responses to regulatory questions. \nInitiative Responsibilities: \nPartner with the Head of Statistical Programming to lead initiatives that implement innovative strategies and technologies to enhance programming processes, driving adoption across the compound studies. \nContribute to establishing departmental Statistical Programming standards and SOPs, and lead implementation of programming strategies, specifications, and standardized analyses across studies within the assigned compound. \nProactively identify gaps and risks in programming capabilities and processes, lead improvement plans, and share lessons learned and best practices across the Statistical Programming team. \nBasic Qualifications: \nMaster’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field. \nAdvanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming. \nIn-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements, with hands-on experience applying these standards and leading programming deliverables for regulatory submissions. \nStrong knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology, with the ability to translate analysis plans into programming requirements. \nExcellent communication and collaboration skills, with the ability to represent Statistical Programming on cross-functional compound teams, influence decisions, and communicate technical risks and recommendations clearly. \nPractical experience with data validation, define.xml generation, and tools such as Pinnacle 21, including preparation and review of supporting reviewer guides and resolution or documentation of conformance findings. \nExperience managing outsourced programming activities and overseeing CROs and contractors, including defining scope and quality expectations, monitoring timelines and budgets, and resolving delivery issues. \nDemonstrated ability to provide technical leadership and mentoring to study programmers and lead a programming team while remaining hands-on in programming and technical review. \nPreferred Qualifications: \n8+ years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment, including demonstrated experience leading programming across multiple studies within a compound or development program preferred. \nBroad expertise in statistical programming and developing compound-level programming strategies, including cross-study standards, resource planning, timeline management, and risk mitigation. \nExperience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.\nExact Compensation may vary based on skills, experience and location.\nPay 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