Statistical Programmer- II
Statistical Programmer- II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Develop test and validate SAS programs to generate analysis datasets (ADaM) TLFs and adhoc reports.
- Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g. FDA EMA).
- Collaborate with Biostatisticians Data Management and Clinical Teams to define specifications and resolve data issues.
- Review and interpret statistical analysis plans (SAPs) and provide programming support accordingly.
- Participate in quality control (QC) and peer review of programs outputs and documentation.
- Maintain accurate and auditready documentation including programming logs annotation and specifications.
- Support integrated summaries of efficacy (Client) and safety (ISS) for regulatory submissions.
- Assist in mentoring junior programmers as needed.
- Bachelors or Masters degree in Statistics Computer Science Mathematics Life Sciences or related field.
- 5 years of SAS programming experience in a pharmaceutical CRO or biotech environment.
- Strong experience with CDISC standards (SDTM ADaM) and regulatory submission processes.
- Handson experience with SAS/Base SAS/Macro SAS/SQL SAS/STAT.
- Familiarity with clinical trial data CRFs and data management processes.
- Ability to manage multiple projects meet deadlines and work independently.
- Excellent communication skills and attention to detail
- Experience with eCTD submissions and FDA guidance
- Exposure to R Python or other statistical tools is a plus
- Knowledge of tools like Pinnacle 21 Review or JMP
- Experience in oncology rare disease or CNS.
Employment Type
Remote
Company Industry
Key Skills
- Business Development
- Customer Service
- Attorney
- CISSP
- Data Analysis
