Overview

Responsible for supporting the Clinical and Statistical Programming (CSP) efforts for specific
projects/studies with SAS. Responsibilities include developing, testing, maintaining, validating,
and documenting SAS programs to meet the project's needs. Work within general programming
standards and procedures to independently perform statistical programming tasks

Responsibilities
• Creates new programs, troubleshoots and updates
programs written by colleagues in support of
design, development and implementation of
technical solutions for integrating, analyzing, and
reporting clinical data.
• Provides comprehensive programming support for
project teams, including development of
programming strategies, standards, specifications
and programmed analysis.
• Independently leads and / or performs
programming assignments across multiple projects
with minimal supervision.
• Provides leadership for ensuring quality of
deliverables by consistently applying programing
standards and complying with regulatory
requirements, protocols, guidance and corporate
and departmental SOPs and work practices.
• Provides statistical programming support to
supplemental or exploratory analyses for regulatory
agencies or any other internal and external ad-hoc
requests.
• Assists in the development and/or maintenance of
departmental procedures and standards.
• Reviews key study documents (e.g., CRFs, DMP,
SAP, data specifications) to ensure alignment with
development team objectives and clarity and
completeness of programming assumptions and
requirements.
• Performs other duties as directed by

Qualifications
• Bachelor's or advanced degree in
statistics, biostatistics, computer
science, or related scientific fields.

Experience
• Minimum 4 years of experience in
the pharmaceutical/biotech
industry for Bachelor's and 2 years
for Master's degree, (or otherwise,
qualified by training or
experience).

Skills
• Advanced knowledge with Base
SAS, including SAS macro
language, is preferred.
• Advanced knowledge with
industry standards, such as the ICH
guidelines, CDISC data standards,
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.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.