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Principal Statistical Programmer - Biometrics

Company:
Mantell Associates
Location:
Massachusetts
Posted:
April 18, 2024
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Description:

Mantell Associates is partnered with an organisation searching for a highly skilled and experienced Principal Statistical Programmer to join their biometrics division.

Principal Statistical Programmer - Responsibilities:

Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures

Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs

Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements

Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance

Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications

Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines

Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues

Identify opportunities for process improvement and optimization in statistical programming activities, driving efficiency and enhancing productivity

Serve as a primary point of contact for clients on statistical programming matters, providing technical expertise, addressing inquiries, and ensuring client satisfaction

Provide training, mentorship, and support to junior members of the statistical programming team, fostering their professional growth and development

Principal Statistical Programmer - Requirements:

Bachelor's or Master's degree in statistics, biostatistics, computer science, or related field

Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry

Proficiency in SAS programming language, including SAS/Base, SAS/STAT, SAS/MACRO, and SAS/GRAPH

Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA, ICH)

Excellent leadership, project management, and communication skills

Proven ability to work effectively in a dynamic, fast-paced environment and manage multiple priorities simultaneously

Experience with programming in R or other statistical software packages is a plus

Familiarity with version control systems (e.g., Git) and programming languages such as Python is desirable

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at .

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