Lead, Statistical Programming

Your role:

• Ensure that outputs meet quality standards and project requirements.
• Guide and ensure well organized, complete up-to-date project documentation, and verification/quality control documents and programs are kept ensuring inspection readiness.
• Read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells etc.) and provide feedback if any.
• Develop and maintain standard programs, macros, templates, and libraries for statistical programming activities.
• Contribute to project-specific objectives and team deliverables.
• Responsible for on-time delivery across concurrent programming deliverables.
• Resolves complex statistical programming obstacles and provides guidance to teams
• Develop annotated CRFs and regulatory submission documentation including Define.xml and data reviewer’s guides.
• Develop programming specifications as per the client requirements and compliant to the CDISC standards and to develop programming plan for statistical outputs (datasets, tables, listings, figures, etc.) supporting clinical study reports, regulatory submissions, and publications.
• Develop/validate CDISC compliant complex datasets (SDTM/ADaM) and Tables, Listings, and Figures (TLFs) using the aCRF, programming specifications, and SAP.
• Serve as a back-up to primary contact for sponsors, vendors, and the project team for study related programming activities.
• Review/approve electronic Case Report Forms (eCRFs) as required.
• Drive/enable limited number of small teams of internal/consultant programmers to make progress on programming activities/deliverables.
• Maintain a high level of professionalism, performance, productivity, and quality.
• Undergo Regulatory trainings, ICH GCP and 21 CFR Part 11 trainings.
• Other statistical programming duties and responsibilities as assigned.

Your Profile:

• Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science or related field or equivalent experience.
• Fluent English (oral and written)
• At least 3 years’ experience in Biostatistics or Statistical Programming within the pharmaceutical industry or related field.
• Experience in planning and coordinating programming activities and leading programming teams is strongly preferred.
• Ability to multitask and prioritize work.  
• Pay close attention in detail, timeliness, and quality
• Strong problem-solving and leadership skills with the ability to contribute creative and practical solutions to problems.
• Excellent team working characteristics, capable of working in cross-functional teams.
• Significant knowledge of drug development and clinical research.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements.
• Must demonstrate the ability to operate in a fast-paced environment.  
• Excellent time management and planning skills.
• Excellent communication skills, both written and verbal.

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being.  Our employees enjoy half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.