Trial Statistical Programmer Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions.Discover Impactful Work:

Provides mentorship and training to junior team members while performing bioinformatics programming for research projects in the Clinical Pharmacology department. Works independently as a lead programmer on select studies, or collaborates with a lead programmer on more complex projects.

Key responsibilities:

• Collaborates with project team leaders and client representatives as the lead programmer or project lead on complex Clinical Pharmacology studies. Conducts team meetings, develops and maintains project timelines, and monitors study budgets while assessing and forecasting resources.
• Takes on leadership role within a project team, actively communicating with other members and following practice documents and SOPs.
• Develops and maintains SAS programs for data transfer between systems, data combination, summary data generation, report generation, and program validation using SAS.
• Manages and documents assignments to meet timelines and deliver high-quality work, being familiar with any relevant contractual obligations or limits.
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
• Provides training, mentorship, and project leadership to junior team members.
• Assists the Department by representing the company at industry conferences, teaching at department meetings, and helping to create training materials. Also contributes to the development of departmental documents and policies.

Education and Experience:

• Bachelor's and/or MS/MA degree in computer science, statistics, biostatistics, mathematics, or related field or equivalent and relevant formal academic/vocational qualification.
• Minimum 4 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
• Programming experiences for studies in Clinical Pharmacology preferred.
• Basic knowledge and background in statistics preferred.

Knowledge, Skills, and Abilities:

• Good understanding and working knowledge of SAS or more programming languages.
• Demonstrated, skillful hands-on experiences in SDTMS / ADaMs /TLFs specifications and programming.
• Good knowledge of Pinnacle 21.
• Excellent verbal and nonverbal communication skills to effectively collaborate with teams and clients, with a strong command of the English language.
• Capable of independently and effectively coordinating and managing multiple assignments with challenging timelines.
• Capable of adapting and adjusting to changing priorities.
• Capable of training and mentoring others.
• Solid project management skills to act as project lead across the most challenging and complex projects.