The Director, Programming Innovation is highly experienced in leading, evaluating, developing and deploying advanced statistical programming methodologies in Clinical Development and has multi-year experience in leading programming effort in successful drug submissions. The incumbent is highly experienced in the programming integration of clinical data in drug development and submission process and will support the senior director of statistical innovation by assessing programming needs and building, maintaining, validating novel statistical programming that access, visualize, analyze and report clinical trial data. A strong individual contributor and a dynamic team leader, the Director of Statistical Innovation collaborates with statistical, clinical, data management and regulatory experts to broadly impact the portfolio by ensuring effective ways to advance medicines to patients.. Principal Responsibilities. Deploy modeling and simulation capabilities and activities in support of drug development scenario planning and program optimization.. Partner with Clinical Applications and Database groups in building and maintaining infrastructure of the programming environment. Develop resource plans and allocate staff in alignment with Clinical priorities. Identify resource constraints or limitations and recommend mitigating actions. Monitor resource demand and capacity to ensure efficient and balanced utilization of internal and external resources across projects.. Provide guidance and solutions to challenging clinical and statistical analytical need, ensure objectives, timelines and quality expectations are met and deliverables comply with regulatory requirements.. Conduct oversight management to ensure that clear programming specifications and expectations are provided according to schedule to support submissions to regulatory authorities.. Operate as a full partner to clinical and scientific leadership. Ensure effective partnership with other functions including clinical, regulatory, operation functions to drive. Operationalize tools (e.g., R-shiny, SAS, R, etc.) and platforms to implement key methodology making diverse approaches available to study teams. Provide expertise and educate staff as needed to ensure clear understanding of data standards (CDISC) and programming practices that adhere to electronic submission package requirements and regulatory guidance.. Department specific/Non-essential responsibilities :. Other duties as assigned with or without accommodation.. Minimum Requirements. Education Required:. Master's degree in Computer Science, Statistics or related field. Experience / Skills:. 12+ years of industry experience in the pharmaceutical or biotechnology field. 5+ years of experience in managing direct employees in statistical/programming field. Demonstrated project and technical leadership qualities, and creative and strategic thinking required. Knowledge of FDA/CHMP guidelines, GCP, Clinical research, Fundamentals of Project Management, working in a matrix-based environment is a must.. Competencies:. Strong understanding of clinical development and clinical trial processes for regulatory submissions. Experience in Modeling and Simulation programming in support of drug development programs. Ability to define and implement CDISC compliant SDTM and ADaM data and specifications. Ability to communicate with clarity and influence to drive change and innovation.. Organizational Relationship/Scope:. This position will work with multiple functions outside of Clinical Development. Key Stakeholders. At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission:. Managing Complexity. Improving L...
Associated topics: administrative coordinator, administrative officer, administrative support, asso, chief operations officer, document, front office, operational support, staff, support

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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