- Title: Principle Biostatistician Programmer
- Code: RCI-3333737
- Location: South San Francisco California (CA) 94080
- Posted Date: 01/26/2021
- Duration: 12 Months
Talk to our Recruiter
- Name:Mangesh Kanade
- Email: email@example.com
- Phone: 908-704-8843 ✖ 260
Principal or Senior Statistical Programmer - Medical Affairs
- This essential team member will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs.
- As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.
- The person will work with biostatisticians, medical leads, data management, and with external vendors if applicable to support activities in the planning, design, development, implementation, and management of data to fulfil reports and summarize information required in support of ad hoc requests in post-marketing clinical trials, investigations, and assessments of claims databases, including health economics and outcomes research project.
- Provides expert support and direction regarding statistical programming design to clinical trials and projects including adhoc requests
- Review and provide input to statistical analysis plan
- Knowledge of statistical concepts, such as p-values, rates and proportions, frequencies, confidence intervals, survival analysis, non-parametric analysis, repeated measures analysis
- Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications.
- Expert in pharmaceutical industry data standards including SDTM and ADaM. Develop SDTM and ADaM specifications, 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).
- Design and programming reports/output to support data managements, drug safety, and clinical monitoring activities.
- 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.
- NDA submission experience is a plus
- Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 8 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.
- Knowledge of R is plus
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Must be strong Principle level with experience to lead projects from scratch.
- Hypertension or oncology experience is a plus
- Must be able to speak to how much involvement in current job, talk about project, how deep is there understanding if they are at a principle level
- Base SAS:
- SAS Macros: