Overview
Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
As a Senior Statistical Programmer, you will be responsible for programming support in the analysis and reporting of clinical trials. You will work closely with biostatisticians, data managers, and clinical teams to develop high-quality statistical programming deliverables in compliance with regulatory requirements and industry standards.
Responsibilities
* Develop, validate, and maintain SAS and R programs for data analysis, visualization, and reporting of clinical trial data.
* Generate CDISC SDTM datasets, analysis datasets (ADaM), tables, listings, and figures (TLFs) for clinical trial reports and regulatory submissions. Should be able to write the SDTM specifications and ADaM specifications based on the SAP and TFL shells.
* Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines.
* Collaborate with statisticians and clinical teams to interpret and implement statistical analysis plans.
* Provide technical leadership and mentor junior programmers in best practices for statistical programming.
* Perform quality control (QC) checks on programming deliverables to ensure accuracy and consistency.
* Participate in the development of standard programming macros and tools to improve efficiency and reproducibility.
* Support regulatory submissions by preparing submission-ready datasets and documentation within Pinnacle 21. Define xml and reviewer guide experience is a plus.
Qualifications
* Minimum 8 years of experience in statistical programming within clinical trials or pharmaceutical/biotechnology industries.
* Proficiency in SAS programming with experience in Advanced SAS, SAS/STAT, and SAS Macro development.
* Strong experience in R programming for statistical analysis and visualization.
* Hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements.
* Solid understanding of clinical trial design, statistical methods, and regulatory guidelines (FDA, EMA, ICH).
* Experience working with clinical data from Phase I-IV studies. RWE study experience is a plus.
* Experience with other statistical software is a plus (Python, JMP, or other data visualization tools).
* Ability to work independently and collaboratively in a team environment.
* Strong problem-solving skills and attention to detail.
* Excellent verbal and written communication skills.
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
#J-18808-Ljbffr