Mgr CDM Programming

Work Schedule

Environmental Conditions

Job Description

Manages a small team within the department responsible for the bioinformatics programming aspects of clinical trials, from design through analysis and reporting. Acts as the lead programmer, project lead, or project oversight lead on multiple projects, overseeing both statistical and programming aspects of clinical trials from design to reporting.
Represents the department to clients on study matters, bid defenses, or submission of clinical data to regulatory authorities. Contributes to proposals and bids, organizes teams, implements study strategies to ensure process and programming efficiencies, and maintains programs for statistical report generation and validation.

• Manages staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching, mentoring, employee counseling, and separations. Approves salary, hiring, corrective actions, and terminations. Reviews and approves time records, expense reports, leave requests, and overtime. Promotes adherence to PPD Equal Employment Opportunity policies and ensures compliance with scientific, ethical, and regulatory standards.
• Serves as a lead programmer or project lead on studies or drug programs of varying complexity. Works with teams and clients to conduct meetings, develop project timelines, assess resources, and manage budgets and contractual obligations.
• May serve in senior project oversight roles or as a contributor/reviewer for regulatory submissions.
• Provides infrastructure support, including representing the company at industry conferences, developing training materials, contributing to policy documents, and process improvement initiatives.
• Enhances knowledge and skills in programming, clinical trials, and pharmaceutical industry developments for self and team members.
• Promotes the company's visibility through publications and conference presentations.
• Interprets and enforces policies, processes, and procedures within the department, with full knowledge of the functional responsibilities.

Qualifications:
Education and Experience:

• MS/MA in computer science, statistics, biostatistics, mathematics, or related field, with at least 3 years of relevant experience, or
• Bachelor's degree in a related field with at least 5 years of relevant experience, with preference for at least 6 years of clinical trial experience as a statistical programmer and 1 year of leadership experience.

Knowledge, Skills and Abilities:

• Strong SAS programming skills and understanding of database structures.
• Excellent organizational skills across projects.
• Ability to independently manage workloads and meet challenging deadlines.
• Adaptability to changing priorities.
• Excellent written and verbal communication skills in English.
• Ability to work effectively in multidisciplinary teams.
• Basic understanding of statistical principles in clinical trial design and analysis.
• Contributing to policy development and programming decisions.
• Strong problem-solving skills.
• Leadership skills demonstrated through project and team management.
• Attention to detail.
• Effective communication with clients, teams, and departments.
• Understanding of project budgeting and risk management.
• Knowledge of clinical trial guidelines (ICH, GCP).
• Delivery-focused and quality-driven approach.