Senior Biostatistical Programming Manager

📋 Description

• In this essential role, you will oversee programming activities that support the obesity therapeutic area.

• This position reports to the Director of General Medicine - Obesity programming within CfOR’s Data & Analytic Center.

• The senior manager will lead the obesity programming team in developing and executing real-world evidence (RWE) observational studies, ensuring timely and quality delivery of results.

• You will be responsible for supervising the US programming team and for planning, organizing, and managing resources to guarantee high-quality and timely delivery of observational research programming outputs.

• The senior manager will spearhead efforts to identify, develop, and implement departmental standards, applications, processes, and training.

• Key responsibilities include: leading, managing, and developing programming staff.

• Provide technical solutions to programming challenges within CfOR.

• Lead and foster technical programming and process improvement initiatives within CfOR.

• Represent the programming function and engage in multidisciplinary project team meetings.

• Manage all programming activities in accordance with agreed resource and timeline plans.

• Ensure that all programming activities within the project comply with departmental standards.

• Write, review, and approve all programming plans.

• Write, review, and approve analysis dataset specifications.

• Review and approve key study-related documents produced by other departments, such as SAPs, CRFs, and Data Management Plans.

• Write, test, and validate software programs in Unix to generate analysis datasets and presentation outputs for reports submitted to regulatory agencies, publications, and other communications.

• Write, test, validate, and execute department-, product-, and protocol-level macros and utilities.

• Supervise the work of outsourced resources assigned to the project.

• Review Requests for Proposals (RFPs) from outsourcing vendors for programming services.

• Lead and/or participate in the development and review of CfOR Policies, Standard Operating Procedures (SOPs), and other controlled documents.

• Participate in study and systems audits conducted by Clinical Quality Assurance (CQA) and external entities, addressing audit questions and findings.

• Engage in the recruitment of programming staff.

• Actively participate in external professional organizations, conferences, and/or meetings.

• Contribute to and take part in intra-departmental and CfOR meetings.

• Support 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 include a Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific discipline.

• For therapeutic area support, a minimum of ten (10) years of clinical research and development programming and management experience is required.

• For system and process support, at least ten (10) years of project management, software application development, and management experience is necessary.

• Familiarity with Drug Development (pre-, early, late, and/or observational) in related industries or academic research.

• Proficient in project planning and management.

• Experience in process improvement leadership.

• Involvement in the development of policies and SOPs.

• Ability to work in international cooperation.

• Proficient in computer programming, preferably in SAS or other procedural languages.

• Understanding of computer operating systems, with a preference for UNIX.

• Experience in Biostatistical Programming within Drug Development.

• Knowledge of Drug Development Processes & Operations.

• Experience in software development and design.

🏝️ Benefits

• A comprehensive employee benefits package that includes 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 applicable.