Principle Biostatistician Programmer, Medical affairs
Vacancy expired!
Principle Biostatistician Programmer - Remote in San Francisco CAKelly FSP is currently seeking a Principle Biostat Programmer to support one of our global sponsor clients. This role is a full-time with no end date, offers our enhanced benefits package. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. Please send your resume to Alicia Cali at or call/text at 216.256.7768 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.
- 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.
- NDA submission experience is a plus
- Supporting Data management function to program and edit, generate patient profiles, perform reconciliations, oversight of CRO in stat program
- Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
- Generation of randomization schemes; unblinding of treatment assignments and appropriate handling of unblinded information.
- Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
- Must be expert of macro creation
- A Master's or Ph.D degree in Statistics, Biostatistics, or Applied Mathematics with 5yrs+ years of experience performing statistical analyses in a regulated environment, preferably medically related including FDA, Google Cloud Platform or other relevant area, is a plus
- (OR) Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field with minimum of 8 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer is REQUIRED
- 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.
- Hypertension or oncology experience is a plus
- Experience with independently setting up study from start and leading team is required
- Experience with oversight of CRO work for outsource model is required
Vacancy expired!