Senior Statistical Programmer

Job Title

Responsibilities:

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 ad-hoc 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 mock-ups

Manage, generate, and/or review acrf.pdf, define.xml, define.pdf, and reviewer's guide documents

Assist in validation of SAS per 21 CFR Part 11

Train and mentor new members and programmers; supervise contract programmers, as needed

Requirements:

Bachelor's 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.