To support the Biostatistics team by carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (Client), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. SDTM and ADaM technical knowledge are preferred. In addition, knowledge of agency requirements including ICH, FDA, and other guidances are beneficial. Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs.
3. Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers.
4. Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process.
* Responsibilities weighting may change significantly based on the incumbent and their assigned areas of responsibility.
Qualifications and education required:
• Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred.
• Minimum 3 years’ experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. 6+ years’ experience preferred.
• Some project experience in a pharmaceutical/CRO programming environment or demonstrated significant leadership of SAS programming activities in a clinical pharmaceutical/CRO environment.
Skills and aptitude required:
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
• Applies good judgment and demonstrates initiative to resolve issues.
• Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required
NOTE: EDUCATION REQUIREMENTS: Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred.
DOMESTIC SCHOOLS PREFERRED. PHARMA INDUSTRY NOT CRO. STABLE WORK HISTORY
Source: Job Diva – Job Listing