Senior Manager, Statistical Programming
About The Position
Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments for cardiovascular diseases. Led by experienced co-founders who previously led MyoKardia, Kardigan possesses a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team. The company is driven by patient needs, authenticity, a commitment to learning, teamwork, and enabling the impossible through innovation and risk-taking. This Senior Manager, Statistical Programming position is within the Clinical Data Sciences & Analytics department and reports to the Head of Statistical Programming. The role is based in South San Francisco, CA or Princeton, NJ, with an on-site requirement of 4 days per week (Monday to Thursday). The Senior Manager will lead statistical programming activities, including hands-on implementation of statistical analyses using SAS/R, quality reviews of deliverables, and managing outsourced programming tasks. This role acts as a crucial link between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and high-quality clinical data delivery. Additionally, the position will contribute to establishing SOPs, programming standards, and modernizing statistical reporting with open-source tools.
Requirements
- Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.
- Minimum of 6 years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment.
- Advanced SAS and R programming skills, with experience using Git for version control required.
- Extensive hands-on experience with SDTM, ADaM, and TLF programming.
- Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
- Good knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology.
- Broad expertise in statistical programming and in developing computing strategies.
- In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials.
- Knowledge of data validation, define.xml generation using Pinnacle 21.
- Results-oriented, with proven problem-solving skills and a strong interest in continued learning.
- Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams.
- Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors.
- Adaptable and able to thrive in a fast-paced, startup environment while managing multiple priorities effectively.
Nice To Haves
- Python programming experience is desirable.
- Experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.
Responsibilities
- Provide programming leadership and oversee study to compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams.
- Serve as the lead programmer to review the SAP, Data Presentation Plan, and Table Shells to align with project objectives and ensure clarity and completeness of programming assumptions and requirements.
- Lead programming team to produce and/or validate SDTM, ADaM, and TLF for CSR and regulatory requests, publication needs, and ad-hoc analyses.
- Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
- Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.
- Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
- Develop 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.
- Develop robust programs to create define.xml. Lead the NDA eSubmission package preparation.
- Implement innovative strategies and technologies to enhance programming processes.
- Establish Statistical Programming standards and deploy programming strategies, specifications, and programmed analyses.
- Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability.
Benefits
- Exact Compensation may vary based on skills, experience and location.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
