Senior Statistical Programmer
Senior Statistical Programmer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Ensure departmental or functional training plans in place and appropriate.
- Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget.
- Generate validate and/or review SDTM domains and ADaM datasets and associated specifications.
- Generate validate and/or review tables figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
- Generate or perform quality control for SAS programs and other study documents (e.g. presentations and reports).
- Maintain complete and auditable documentation of all programming activities.
- Manage datasets and output across SAS programs studies and indications to ensure consistency.
- Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance regulatory agencies or any other internal and external adhoc requests.
- Manage programming testing and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
- Develop and/or maintain departmental procedures and standards.
- Review CRFs edit check specifications and table figure and listing mockups.
- Manage generate and/or review and reviewers guide documents.
- Assist in validation of SAS per 21 CFR Part 11.
- Train and mentor new members and programmers; supervise contract programmers as needed.
- Bachelors degree in Statistics Mathematics Computer Science or a related field required.
- Minimum of 6 years biotechnology/pharmaceutical/CRO industry experience as a statistical programmer.
- Prior experience overseeing statistical programming contractors required.
- Compound oversight experience highly preferred.
- Extensive knowledge of SAS Macros highly preferred in addition to knowledge of Base SAS SAS/STAT SAS/Graph SAS/SQL and SAS/ODS.
- Experience working with other languages or software (R Python Spotfire) in validated environments is strongly preferred.
- Demonstrates extensive knowledge with industry standards such as the ICH guidelines CDISC standards/implementation guides 21 CFR Part 11 and FDA guidelines.
- eCTD NDA submission experience is a must.
Employment Type
Full Time
