SAS Developer/Biostatistician

Index Analytics, LLC, is a rapidly growing Baltimore-based small business providing health related consulting services to the federal government. At the center of our company culture is a commitment to instilling a dynamic and employee-friendly place to work. We place a priority on promoting a supportive and collegial team environment and enhancing staffs experience through career development and educational opportunities. The SAS Developer/Biostatisticianwill be responsible for developing and implementing statistical code in SAS and R, focusing on clinical trial and adverse event data. The ideal candidate will be proficient in the Enterprise Performance Life Cycle (EPLC) framework and have a thorough understanding of data standards such as CDISC. The SAS Developer/Biostatistician will provide statistical and developmental expertise to support requirements, development and testing of enhancements, routine maintenance tasks, and reported issues (help desk requests, defects, etc.). They will develop appropriate solutions and communicate risks to the team to maintain the accuracy and stability of the application. The SAS Developer/Biostatistician authors, edits, and reviews substantive, complex documentation reflecting detailed knowledge of functional areas as identified in the statement of work. Responsibilities Work within an agile development team to implement and maintain application features within the FDA Enterprise Performance Life Cycle (EPLC) using FDA tools like Jira and Git Hub Implement statistical methodologies used in clinical trials and pharmacovigilance settings, e.g. common statistical tests, regressions, survival analysis, etc. Develop and validate statistical code in SAS and R to support clinical trial data analysis. Ensure compliance with CDISC standards for clinical trial data (e.g., SDTM, ADaM). Perform data quality control and validation of statistical programs and datasets. Interpret and communicate statistical findings to clinical teams and stakeholders. Participate in design and requirements discussions for enhancements or maintenance tasks that may involve changes or impacts to SAS programs. Create new technical documentation and make updates to existing documentation, as required, for each release. Perform root cause analysis of issues reported by reviewers and develop recommendations for resolution Remain current with advancements in biostatistics, clinical research methodologies, and data standards. Qualifications US citizen, or lived in the US for 3 of the last 5 years Ability to obtain Public Trust level clearance Bachelors degree or higher in Biostatistics, Statistics, or a related field. 5+ years of experience in biostatistics, preferably in the pharmaceutical or biotechnology industry. 5+ years programming for diverse data analytics/statistical analysis programs using SAS Demonstrated experience in writing, debugging, and optimizing R code for data analysis, statistical modeling, and data visualization. Knowledge of BASE SAS, SAS Advance and SAS Enterprise Guide Hands-on experience in writing complex SAS SQL queries using PROC SQL, DATA steps, SAS Macros, and SAS Graph Extensive experience using CDISC data and the application of basic statistical procedures Ability to perform reverse engineering and document findings Experience with SAS performance tuning. Ability to integrate with other enterprise systems including single signon (Oracle, Active Directory) Ability to interact with the customer base including medical officers and statisticians Excellent written and oral communication skills Willingness to serve in cross functional roles as needed to ensure business continuity Proficiency in MS Office suites including Word, Excel and PowerPoint Prior experience with Food and Drug Administration or other HHS agencies is preferred but not required. Index Analytics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Attention Candidates: We're dedicated to ensuring a safe and transparent recruitment process for all candidates and have implemented robust measures to protect your personal information. Please be aware that all employment-related communications will originate from a secure portal (NAME@msg.paycomonline.com) or a corporate email address (NAME@index-analytics.com).If you have any concerns, please don't hesitate to reach out to us atrecruiting@index-analytics.com.