San Francisco, CA
Industry: Pharmaceuticals & Biotech•
11 - 15 years
Posted 42 days ago
Will be responsible for being a technical resource and mentor to other statistical programming analysts. Will lead technology and process initiatives and design/development global utilities and macros. Provide expertise and hands on support to clinical projects across multiple therapeutics areas. Contribute in Building Statistical Programming Infrastructure. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Will typically have IC and MGMT staff reporting into this level.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Work with IT ensuing that local IT infrastructure meets Biometrics needs and global standards. Adhere to principles of GCP and develop, apply and promote consistent programming standards through standard processes and SOPs. Identify areas of deficiency requiring SOPs or guidelines and develop and execute a plan to rectify. Administratively and functionally manage statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development. Lead data standardization efforts (SDTM, ADaM, and Define.xml) per CDISC, EMA/FDA submission requirements. Ensure safety reports are following the standards and are consistent across compounds or studies. Provide timeline and resource forecasts for statistical programming deliverables. Mentor statistical programmers on team performance and relevant therapeutic areas. Hiring of additional staff. Responsible for processing of clinical data required for analysis of clinical trials for Phase 1-4. Initiate programming environment. Develop SAS coding and table templates for preparing, processing and analyzing clinical data. Create/acquire tools to improve programming efficiency and quality. Validate work of other programmer/analysts at CROs or in-house. Perform vendor qualifications. Manage CROs regarding programming issues and activities to ensure timely delivery of tables and data listings.
Provide guidelines, review, and QC CRO deliverables to ensure the quality of deliverables. Participate in the lead task forces and new initiatives, while maintaining current knowledge of programming practices and development within the industry. Work with other functional groups to identify areas where statistical programming support can enhance efficiency and quality.
Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Ensure SOPs have been developed properly. Ensure statistical programming tasks has been conducted in a compliant and timely manner with high quality across all projects. Ensure the computer system and network are set up appropriately. Administratively and functionally manage statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development.
A minimum of a Bachelor's degree in Computer Science, Mathematics, Statistics, and/or related areas is required. A Masters or PhD is preferred. Equivalent experience may be accepted.
A minimum 12-15 years relevant career experiences in the pharmaceutical or biotechnology industry. A minimum 5-8 years experiences in managing statistical programming group and activities.
Excellent knowledge of SAS programming and associated features and their applications in pharmaceutical industry environments-in particular clinical trial data setting. Experience with Clinical Study Reports and NDA or BLA submissions. Technical expertise, working in either a pharmaceutical or CRO FDA regulated environment. Excellent knowledge of ICH, FDA, and GCP regulations and guidelines. Strong well-rounded technical skill, SAS, CDISC, Submission CRTs. Customer & Industry Knowledge. Advanced knowledge of FDA, EMA, and ICH guidances; CDISC and ADaM and electronic submissions. Advanced knowledge of integrated summary of data. Strong understanding of clinical trial data and must be extremely hands on in data analysis and reporting of analysis results. Thorough understanding of relational database components and theory. Excellent oral and written communication skills.