Senior Manager, Scientific Programming

General Description:

The Senior Manager, Statistical Programming Project Lead will be responsible for a product area and support multiple indication development programs. The incumbent will lead the global development of the project in scope and provide guidance and supervision for the successful completion of all programming deliverables.

Essential Functions of the Job:

• Collaborate with lead project Biostatistician in project strategic planning and provide overall guidance to the programming team in creation, implementation, and maintenance of programming development plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned; ensure that all programming has been carried out per industry and internal standard practice.

• Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines

• Contribute to the development and implementation of programming resource algorithms.

• Collaborate with programming managers and project leads, lead the effort of project resource planning and tracking.

• Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables

• Contribute to strategies for programming related matters in submission to regulatory agencies, publications and other communications as needed

• Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities

• Be a technical resource for programming groups to provide advice on complex programming tasks and/or standards.

• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents

• Oversee the projects for the creation of analysis datasets, production / validation of output, and review of annotated case report forms

• Lead the statistical programming support of FDA/EMEA/CDE regulatory submissions follow CDISC standards

• Contribute to departmental process and standards initiatives such as tools and CDISC standards.

• Collaborate and support the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.

• Oversee the work in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards.

• Lead the development of TAUG (therapeutic area users guide) following CDISC Industry standards

• Other duties as assigned

Supervisory Responsibilities:

• Not Applicable

Computer Skills:

• SAS (Base, Macro, SQL)

• R (data manipulation, analysis, visualization)

• Python (scripting, data manipulation)

• SQL / relational databases

Other Qualifications: ?

• Master's degree in a quantitative or scientific field (e.g., Computer Science, Statistics, Mathematics, Life Science) preferred with 5+ years of relevant experience

• Experience with CDISC standards (SDTM, ADaM)

• Familiarity with regulatory submission deliverables (e.g., TFLs, ISS/ISE, eCTD)

• Knowledge of clinical data structures and study designs

• Experience with ClinPharm/PK analyses

• Familiarity with workflow automation and reproducibility

• Ability to oversee multiple studies or programs

• Vendor/CRO oversight experience

• Cross-functional collaboration with Statistics, Clinical, Data Management, Clinical Pharmacology, Medical Writing, and Regulatory

Travel: Minimum

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.