Biostatistical Programming Mgr

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><p><b>Biostatistical Programming Manager</b></p><p><b>What you will do</b></p><p>Let’s do this. Let’s change the world.</p><p>Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions.</p><p></p><p><b>Key Responsibilities:</b></p><ul><li><p>Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer</p></li><li><p>Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables</p></li><li><p>Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team</p></li><li><p>Participate in establishing the programming scope for a deliverable with the statisticians and the study team</p></li><li><p>Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project</p></li><li><p>Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects</p></li><li><p>Represent GSP at the Clinical Study Team (CST)</p></li><li><p>Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications</p></li><li><p>Initiate cross-functional team meetings as necessary</p></li><li><p>Perform significant hands-on statistical programming, particularly for those most challenging deliverables</p></li><li><p>Manage individual programmer work assignments to ensure timely, high-quality deliverables</p></li><li><p>Provide technical leadership and guidance for study programming team</p></li><li><p>Coordinate and monitor data issue reporting and resolution</p></li><li><p>Coordinate with other SLPs to providing consistent deliverables across studies within a product</p></li><li><p>Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.)</p></li><li><p>Provide training and guidance to other programmers</p></li><li><p>Assume some product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL).</p></li></ul><p></p><p>This position will be located at Amgen India (Hyderabad).</p><p></p><p><b>Win</b></p><p><b>What we expect of you</b></p><p>We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.</p><p></p><p><u>Basic Qualifications</u>:</p><ul><li><p>BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 6 years of statistical programming experience in clinical development environment.</p></li><li><p>Thorough understanding of clinical trial processes, from data collection to analysis reporting</p></li><li><p>Proven record of superior statistical programming and problem-solving skills within clinical development environment</p></li><li><p>Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end</p></li><li><p>In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards</p></li><li><p>Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others</p></li><li><p>Experience in data quality and compliance check tools</p></li><li><p>Excellent project management skills and ability to lead multiple projects effectively</p></li><li><p>Excellent oral and written English communication skills</p></li><li><p>Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners</p></li><li><p>Willingness and ability to provide guidance to team members on technical and process questions</p></li></ul><p></p><p></p><p><u>Preferred Skills</u>:</p><ul><li><p>MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects</p></li><li><p>Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming</p></li><li><p>Prior regulatory submission experience for drug approval</p></li></ul><p></p><p><b>Thrive</b></p><p><b>What you can expect of us</b></p><p>As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.</p><ul><li><p>Vast opportunities to learn and move up and across our global organization</p></li><li><p>Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</p></li><li><p>Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</p></li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.