Mission
Biopharmaceutical
HeadofStatisticalProgramming
“Head of Statistical Programming at Mission. Skills: Statistical programming strategy, AI and technical innovation, Quality and compliance oversight, People and leadership, External partnerships and outsourcing, Statistical analysis environments and tooling, Budget and strategic planning, Portfolio and capacity management, Continuous improvement and change, Regulatory and payer submissions. Set the strategic direction for statistical programming within Quantitative Sciences.. Lead the evolution o”
What You'll Achieve.
Deliver submission-quality outputs that stand up to the highest scientific and regulatory scrutiny.; Increase speed and quality through AI-enabled capabilities.; Generate evidence efficiently.; Reliably submit global dossiers.; Quickly reach patients who need our medicines.; Ensure compliance with CDISC and other global standards.; Improve data analysis and operational delivery.; Ensure on-time, high-quality contributions to global partner governance.; Ensure clarity, traceability, and inspection readiness for submissions.
Industry & Context.
Solving complex problems.
What They're Looking For.
Must Have
At least 10 years experience leading the development of Programming strategy within a business unit while contributing to enterprise-wide Programming strategy, including leadership of broader Quantitative Sciences strategy., Responsibility for people development strategy within a programming function and leadership of a group of leaders., Accountability for the programming strategy for quality oversight of a drug portfolio., Expertise developing and executing outsourcing strategies to maintain the highest quality of programming contributions to global governance of external partners (e. g. , CROs)., Experience with the development, implementation, administration, and budget management of statistical analysis environments utilized in the development, reporting, and submission of global regulatory dossiers., Demonstrated ability to plan and manage complex departmental budgets, with accountability for quarterly, annual, and multi-year forecasting and input to corporate strategic planning., Accountability for compliance to standards and automation usage (including AI, CDISC, etc. ) across therapy areas/R&D units., Delivery of continuous improvement and large-scale change projects within the function or across R&D., Leadership of portfolio-level programming capacity management for a therapy area/R&D unit., Provision of strategic, scientific, and programming advice to teams regarding submission of programming deliverables to global regulatory and payer authorities., Leadership of leaders within a Programming organization.
Nice to Have
Advanced degree in statistics, biostatistics, computer science, mathematics, engineering, or a related discipline., Deep expertise with CDISC standards and modern statistical programming languages and tools (e. g. , SAS, R, Python) and their application in validated environments., Hands-on leadership establishing and operating scalable statistical computing environments, with a track record in global dossier submissions., Experience building AI governance and automation frameworks that improve quality, speed, and reproducibility in clinical programming., Demonstrated success governing CROs/strategic suppliers at scale, including quality oversight, KPIs, risk management, and inspection readiness., Change leadership across large R&D organizations, including operating model evolution and capability-building., Background in rare disease, orphan indications, or other complex therapeutic experience with payer/HTA submissions is a plus.
What You'll Do.
Set the strategic direction for statistical programming within Quantitative Sciences.
Lead the evolution of advanced analytics
Define and own the programming strategy for quality oversight across the drug portfolio.
Lead a group of programming craft and execute the people development strategy.
Shape and govern outsourcing strategies with Contract Research Organisations and other partners.
Oversee the development
and budget management of statistical analysis environments.
Plan and manage a complex departmental forecast quarterly
Lead portfolio-level programming capacity planning across therapy areas/R&D.
Drive continuous improvement and large-scale change initiatives within the function and across R&D.
and programming guidance for submissions to global regulatory and payer authorities.
How You'll Work.
Team & Collaboration
Aligning therapy areas and enterprise priorities.; Working with leaders who deliver results study by study and submission by submission.; Mobilizing leaders and partners to deliver at pace.; Contributing to global partner governance.; Providing strategic, scientific, and programming guidance to teams.; Sitting shoulder-to-shoulder with clinical, regulatory, and data science peers.
Communication Scope
Providing strategic, scientific, and programming guidance.
Process & Methodology
Managing complex departmental budgets., Quarterly, annual, and multi-year forecasting., Driving large-scale change initiatives., Managing outsourcing strategies., Capacity planning.
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