Job Description
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 Principal Statistical Programmer (“Programmer”) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials.
Responsibilities
• Exceed expectations and responsibilities of a Senior Statistical Programmer
• Understand and implement CDISC and other regulatory standards
• Follow internal SAS programming conventions
• Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor
• Coordinate and ensure the accuracy and completeness of activities for assigned support programmers
• Create and maintain project timelines
• Design, develop, document and validate tools and macros to improve quality and efficiency of processes
• Prepare and review 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
• Perform ad hoc analyses of current and legacy databases
• Review and provide input on case report form design
• Serve as a subject matter expert
• Train and mentor others in task execution
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs
• Develop department training materials and deliver trainings to the team
• Drive/facilitate/actively engage in department initiatives
• 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
• Participate in the development and revision of department SOPs
• Business Development
• Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities
• Assist in the preparation and review of monthly financial reporting
• Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
• 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 6 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, ****** orientation or ****** 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.
The Principal Statistical Programmer (“Programmer”) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials.
Responsibilities
• Exceed expectations and responsibilities of a Senior Statistical Programmer
• Understand and implement CDISC and other regulatory standards
• Follow internal SAS programming conventions
• Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor
• Coordinate and ensure the accuracy and completeness of activities for assigned support programmers
• Create and maintain project timelines
• Design, develop, document and validate tools and macros to improve quality and efficiency of processes
• Prepare and review 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
• Perform ad hoc analyses of current and legacy databases
• Review and provide input on case report form design
• Serve as a subject matter expert
• Train and mentor others in task execution
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs
• Develop department training materials and deliver trainings to the team
• Drive/facilitate/actively engage in department initiatives
• 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
• Participate in the development and revision of department SOPs
• Business Development
• Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities
• Assist in the preparation and review of monthly financial reporting
• Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
• 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 6 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, ****** orientation or ****** 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.
💡 Quick Summary
Seeking a career-building opportunity? The Principal Statistical Programmer position is now open for candidates interested in the Data Entry Jobs sector. This role in Ahmedabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Data Entry Jobs is a plus.