Penfield Search Partners
Contact: Linda Aronova 646.882.9021 email@example.com
- In collaboration with Statistical Programming therapeutic area units (TAUs) lead, this position serves as a key contributor in the development of Statistical Programming strategies including outsourcing and oversight strategies, standards and processes.
- Assists Statistical Programming TAU lead in key operational planning activities to implement department strategy for the specific TAUs.
- Serve as the lead programmer and manages multiple clinical projects mainly consisting of CRO programmers to implement Statistics and Statistical Programming strategies and provide programming expertise and capabilities in support of clinical studies, global development programs, regulatory submissions, and marketed products
- Serve as the lead programmer and manage statistical programming activities across clinical projects for designated TAUs to ensure timely and accurate design and execution of analysis databases and data presentations and to maximize effectiveness and efficiency in use of internal and external (CRO) programming resources
- Serves as a key contributor in the development of Statistical Programming strategies including outsourcing and oversight strategies, standards, processes related to statistical analysis, reporting and regulatory submission of clinical study data to increase efficiency of the Statistical Programming function and enable global data access and integrability.
- Assists Statistical Programming TAU lead to ensure successful implementation of Statistical Programming strategies and efficient execution of the statistical analyses for the assigned clinical projects.
- Leads and organizes programming activities for assigned clinical projects, defines resource requirements and manages timelines across studies for assigned clinical projects to achieve timely and accurate deliverables.
- Provides technical leadership and ensures adequate statistical programming support for assigned projects, and directly leads particularly complex and important regulatory submissions, global programs and clinical studies or ad-hoc analyses:
- Ensures proper definition and management of standards for submission data, analysis data sets and reporting using applicable regulatory or company global standards
- Leads and directly involves as necessary in development and maintenance of SAS computer programs and related processes to produce statistical analysis output, perform data manipulations or verification (QC) of study and cross-study analysis data and results, including preparation of regulatory submissions
- Identifies vendor requirements and provides oversight of statistical programming services of external vendors to assure timeliness, quality and consistency of statistical programming deliverables for assigned clinical projects
- Provides senior level review of deliverables and technical support for other programmers
- Evaluates existing and new regulations and global guidelines as well as industry trends relevant to statistical programming , timely addresses critical issues and proposes strategic initiatives and solutions for assigned clinical projects.
- Serves as the point person to represent Statistical Programming in collaborations and initiatives within broader global company R&D organization, such as global process improvement, global quality management system improvement, etc.
- Represents Statistical Programming on related local and global task teams
- Represents Statistical Programming in external professional initiatives, organizations and forums, such as CDISC, SAS Users Groups, etc.
- Complies with all applicable regulatory requirements and procedures
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BS or MS in Statistics, Biostatistics, Computer Science, or related analytical field
- 10 + years (MS) or 12+ years (BS) SAS programming experience in the pharmaceutical/CRO industry with support of clinical trials across all phases of development including NDA/AMA/CTD submissions
- 6+ years of CRO/Vendor oversight experiences
- In-depth knowledge of statistical programming techniques, processes, and systems, and SAS programming language
- Solid knowledge of general programming and computing principles, familiarity with technologies and products related to statistical programming, databases and computing environments.
- Strong programming, databases and computing environments. Strong knowledge of SAS software products related to the pharmaceutical industry, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office)
- Good knowledge of FDA, EMA, ICH and other regional and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions, e.g. CDISC standards
- Strong project management skills
- Excellent oral and written communications skills