Sr. Statistical Programmer
Proclinical is currently recruiting for a Senior Statistical Programmer with a leading biopharmaceutical company located in San Diego, CA. Successful candidate will generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
- Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Maintain complete and auditable documentation of all programming activities.
- Review output across SAS programs to ensure consistency.
- Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
- Participate in the development and/or maintenance of departmental procedures and standards.
- Review CRFs, edit check specifications, and table mock-ups.
- Works effectively with cross functional groups, study team, and vendors.
- Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
- May assist in creation of table, figure, or listing mockups under supervision of statisticians.
- May train and mentor new programmers.
Skills and Requirements:
- Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- NDA submission experience is a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 312-291-4181 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.