4 Programmer Ii Jobs

Job Title: Senior Statistical Programmer II Career Level: D Introduction to role: Are you ready to make a significant impact in the world of rare disease biopharma? As a Senior Statistical Programmer II, youll be at the forefront of developing and validating programs that create datasets conforming to Alexion and CDISC standards. You will play a pivotal role in generating Tables, Listings, and Figures for analysis purposes. Depending on the complexity of the study, you may lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Your expertise will guide and mentor junior programmers, while your ability to integrate statistical concepts with SAS Programming will drive efficiency and effectiveness. Are you prepared to take on this challenge? Accountabilities: Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM, and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems. Clearly communicate processes and standards with management and team members. High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, youll find yourself immersed in a culture that thrives on innovation and collaboration. Our commitment to transforming complex biology into transformative medicines is unwavering. With a rapidly expanding portfolio in rare disease biopharma, youll have the chance to grow and innovate alongside exceptional leaders and peers. Our entrepreneurial spirit fosters autonomy and connection, empowering you to explore new ideas while meeting the needs of under-served patients worldwide. Here, your career is not just a path but a journey to making a difference where it truly counts. Ready to embark on this exciting journey with us? Apply now to join our team! 04-Jun-2025 04-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com . Alexion participates in E-Verify.

Job Title: Senior Statistical Programmer II Career Level: D Introduction to role: Are you ready to take on a pivotal role in the development and validation of programs that create datasets conforming to Alexion and CDISC standards? As a Senior Statistical Programmer II, you will be at the forefront of crafting Tables, Listings, and Figures (TLFs) for analysis purposes. Depending on the projects size and complexity, you may lead programming efforts, ensuring alignment with ICH guidelines, Good Clinical Practices, and regulatory requirements. Youll also have the opportunity to mentor fellow programmers and represent Statistical Programming in meetings with internal and external clients. Are you prepared to integrate statistical concepts with SAS Programming efficiently and effectively? Accountabilities: Support development of technical programming specifications for SDTM, ADS, or ADaM standards. Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems. Clearly communicate processes and standards with management and team members. High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. At AstraZeneca, youll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients lives. With a rapidly expanding portfolio, youll have the chance to grow alongside a team that values diversity, inclusiveness, and the power of connection. Here, your career is more than just a path its a journey towards making a meaningful difference. Ready to make an impact? Apply now to join our team! Date Posted 02-Jun-2025 Closing Date 02-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com . Alexion participates in E-Verify.

Statistical Programmer II Location: Ahmedabad, Gujarat, India Requisition Number 690 On-site Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Statistical Programmer II ( Programmer ) will have experience in all required areas of a Statistical Programmer I. The Statistical Programmer II is responsible for providing programming support for clinical trials. Responsibilities: Exceed expectations and responsibilities of a Statistical Programmer I Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions May serve as programming lead with responsibility for coordination of activities and timelines May prepare programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: SDTM, ADaM or other derived datasets Tables, listings and figures Review and provide input on case report form design Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures Additional Responsibilities Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 2 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required

On-site Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. The Senior Statistical Programmer ( Programmer ) will have experience in all required areas of a Statistical Programmer II. The Senior Statistical Programmer is responsible for providing programming support for clinical trials. Responsibilities: Exceed expectations and responsibilities of a Statistical Programmer II Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on assigned studies Coordinate and ensure the accuracy and completeness of activities for assigned support programmers Create and maintain project timelines Support the development of tools and macros to improve quality and efficiency of processes Prepare programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: Analysis datasets (SDTM, ADaM, other derived datasets) Tables, listings and figures xml/Reviewer s Guide Integrated summaries Analysis datasets (SDTM, ADaM, other derived datasets) Tables, listings and figures xml/Reviewer s Guide Integrated summaries Perform ad hoc analyses of current and legacy databases Review and provide input on case report form design Serve as a mentor to other programmers Maintain awareness of scope of work to actual work, alerting management of potential change orders or resourcing needs Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures May participate in the development and revision of department SOPs Business Development May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc. Additional Responsibilities May assist in the preparation and review of monthly financial reporting May promote visibility outside of the functional area and effectively interact cross-functionally and in industry May participate in candidate interviews Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 4 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. Equal Employment Opportunity It is Advanced Clinical s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.