SENIOR SAS PROGRAMMER Esperion Therapeutics Inc.
THIS JOB HAS EXPIRED Esperion?s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance.
Reports to: Director, Biostatistics
Department/Cost Center: Clinical/300
Location: US ? Remote
Essential Duties and Responsibilities include but are not limited to the following:
Performing all SAS programming tasks required for clinical trial analysis and reporting.
Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
Develop standard macros and/or tools in SAS for data analysis and reporting.
Assist with statistical quality assurance review.
Review deliverables before transfer to either internal or external clients.
Ensure that SAS programs developed for specific protocols are effectively portable to other protocols (Reusable code).
They utilize SAS and other analysis software in the creation of tables, figures and listings and work closely with project managers and statisticians, as a project team member, in model design.
Performs exploratory statistical analysis using the model provided by the statistician ? analyzes, tests, and modifies computer code and model design based on findings.
Support for pharmacovigilance activity programming may be required.
Oversight for programming deliverables from external vendors.
Support the regulatory submission activities; provide input into data standards and submission package planning.
Liaison between internal and external service providers to ensure efficient and timely communication on statistical/programming projects.
BS degree in computer science or related field with a minimum of 5 years of biotech or pharmaceutical industry experience required; MS degree in computer science or related field preferred; or equivalent combination of education, training and experience.
Experience leading SAS programming projects in the pharmaceutical industry demonstrated by the ability to independently act as the point of contact on the statistical programming for all phases of clinical trials.
Proficient in industry standards, medical terminology, and clinical trial methodologies.
Advanced knowledge in Base SAS, SAS/STAT, SAS Graph and SAS Macro Language.
Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
Understanding of Electronic Submissions.
Proficient in CDISC implementation of SDTM and ADaM standards.
Recent NDA or BLA submission experience preferred.
Timeline & deliverable management for programming outputs.
All qualified applicants are requested to submit a cover letter and CV via email to firstname.lastname@example.org
||Ann Arbor, MI |
THIS JOB HAS EXPIRED