Senior Biostatistical Programming Manager

Role Overview

• In this vital role you will be responsible for programming activities supporting the obesity therapeutic area
• This individual will report to the Director of General Medicine
• Obesity programming in CfOR’s Data & Analytic Center
• The senior manager provides leadership to the obesity programming team in the development and execution of real-world evidence (RWE) observational studies and ensures adequate and timely delivery of results
• The individual is responsible for oversight of the US programming team and planning, organizing, and managing resources to ensure high quality and timely delivery of observational research programming deliverables
• The senior manager leads and contributes to efforts to identify, develop and implement departmental standards, applications, processes , and training.
• Key activities include: Lead, manage , and develop programming staff
• Provide technical solutions to programming problems within CfOR
• Lead and develop technical programming and process improvement initiatives within CfOR
• Represent the programming function and participate in multidisciplinary project team meetings
• Project manage all programming activities, according to agreed resource and timeline plans
• Ensure all programming activities on the project adhere to departmental standards
• Write and/or review and approve all programming plans
• Write and/or review and approve analysis dataset specifications
• Review and approve key study-related documents produced by other functions, e.g. SAPs , CRF, Data Management Plan, etc.
• Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
• Write, test, validate and execute department-, product
• and protocol-level macros and utilities
• Oversee the work of outsourced resources assigned to project
• Review Requests for Proposals (RFPs) from outsourcing vendors for programming services
• Lead and/or participate in the development and review of CfOR Policies, SOPs and other controlled documents
• Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
• Participate in the recruitment of programming staff
• Actively participate in external professional organizations, conferences and/or meetings
• Provide input to and participate in intra-departmental and CfOR meetings
• Contribute to the continuous improvement of programming, CfOR, and Research and Development ( R&D )

Requirements

• Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience OR Bachelor’s degree and 6 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• Preferred Qualifications Bachelor’s or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
• For therapeutic area support, ten (10) years clinical research and development programming and managing experience
• For system and process support, ten (10) years project management, software application development and managing experience
• Drug Development (pre-, early, late and/or observational) in related industries or academic research)
• Project planning and management
• Process improvement leadership
• Participation in the development of policies and SOPs
• International co-operation
• Computer programming, preferably SAS or other procedural languages
• Understanding of computer operating systems, UNIX preferred
• Biostatistical Programming within Drug Development
• Drug Development Process & Operations
• Software development & design.

Tech Stack

• Unix

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.