This Statistical Programming Lead will effectively lead, manage and coordinate the statistical programming activities of the Statistical Programming projects to ensure department, program and study level goals and objectives are consistently met to the highest standard of quality and timely completion of all projects. This position is responsible for planning and providing oversight and coordination of programming of datasets, creating data files, and programming statistical analyses in support all development programs, and will work closely with biometrics colleagues, clinical operations and IT personnel and CROs. S/he will be responsible for assisting others with the use of data files for various clinical projects. The Statistical Programming Lead will demonstrate the ability to leverage her/his experience to innovate, improve and streamline workflows and processes.
Job Function and Description
- Lead programming activities by planning and risk managing deliverables
- Manage and coordinate all statistical programming related tasks with project management, clinical operations, CROs, and other departments
- Utilization of professional expertise in writing and validating programs (primarily SAS) for analysis datasets, tables, figures and listings for clinical studies and/or for regulatory submissions
- Prepare and/or review specifications for analysis datasets, pooled datasets and tables, listing and figure outputs
- Implement effective tracking and reporting to monitor staff workload and optimize staff utilization.
- Function as primary point of contact for programming activities-
- Provide oversight and guidance to CRO for all statistical programming related activities, including development and validation of ADaM
- Review/develop related programming standard operating procedures, work instructions and templates, as needed
- Review and interpret statistical analysis plans (SAP) and provide comments as needed.
- Manages data release and review for clinical projects; reviews and participates in QC and finalization of various documents, including abstracts, posters, manuscripts, publications, press releases, study reports, regulatory documents, etc.
- Develop processes, and software for the analysis of clinical study data.
Education and Experience Requirements
- Develop organization-wide macros, tools, and processes to generate outputs and electronic components required for clinical studies and regulatory submissions.
- Work with IT and Data Analytics improving processes.
Key Skills, Abilities, and Competencies
- The ideal candidate will have a Masters degree in Computer Science, Mathematics or health services related field with 10+ years of SAS Programming experience in pharmaceutical industry, with at least 5+ years of leading statistical programming projects
- Demonstrated ability to lead, manage and programmatically support the process of development of tables, listings and figures at a clinical trial report level, as well as from an integrated analysis perspective.
- Demonstrated expertise and ability to program within CDISC standards (mostly ADaM), develop supporting documentation (Define.xml)
- Experience in FDA/EMA regulatory submissions.
Required skills for this position:
Complexity and Problem Solving
- Expert in CDISC Standards, including SDTM, ADaM
- Expert in SAS programming techniques used in pharmaceutical industry. Must have extensive knowledge in SAS Macro facility
- Good understanding in statistical methods used in study analysis.
- Ability to review protocol and SAP and provide feedback.
- Good knowledge of all phases of drug development, including early and late phase clinical development and submission.
- Good understanding in Good Programming Practise in pharmaceutical industry.
- Good verbal and written skills
- Good interpersonal skills; strong teamworking ability
- Fundamental knowledge of GCP standards
- Fundamental knowledge if ICH guidelines
- Fundamental knowledge of U.S. Code of Federal Regulation (CFR)
- Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry
- Excellent problem-solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible.
- Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects
- Ability to plan and think strategically and critically
Internal and External Contacts
This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical, non-clinical, regulatory, medical, safety, R&D, IT, Data Analytics, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.