Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Serves as a lead programmer or project lead on selected studies or drug programs of all complexity and size scale. In these roles, works directly with teams and clients to conduct team meetings, develop and maintain project timelines, assess and forecast resources needed, is accountable for study budgets and familiar with any relevant contractual obligations or limits with our clients.
• May serve in a senior project oversight role on selected projects.
• May serve in a contributor or reviewer role of key submission materials for regulatory authorities.
• Provides general infrastructure support to the department. Examples include representing the company at industry conferences, presenting/teaching at department meetings, establishing training materials for the department, contributing to documents or policies, and contributing to process improvement and department initiatives.
• Increases knowledge base and professional skills for self and junior team members, in areas including programming technology and techniques, clinical trials, and developments in the pharmaceutical industry.
• Works to increase the visibility of the company by encouraging the publication of articles in industry journals and presentations at conferences.
• May manage staff of small team, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific, ethical, and regulatory standards.
• Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility.
• Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives. A portion of the time may be spent performing individual tasks
• Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 3 years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 5 years of experience that provides the knowledge, skills, and abilities to perform the job requirements

• Preferred is at least 6 years of clinical trial experience as a statistical programmer and at least 1 year of leadership experience
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Programming experiences for the studies in Clinical Pharmacology is strongly preferred. Good knowledge and background in statistics are preferred.
• In-depth understanding and expert level knowledge of SAS or more programming languages
• Expert level knowledge and highly resourceful hands-on experiences in SDTMS/ADaMs /TLFs specifications and programming
• Good Knowledge of Pinnacle 21
• Strong SAS programming skills and understanding of database structures
• Strong organizational skills across individual projects
• Capable of independently and effectively organizing and managing own and team work loads, and completing multiple assignments with challenging timelines
• Ability to adapt and adjust to changing priorities
• Excellent written and verbal communication skills
• , including proficiency in the English language
• Capable of working in a multi-disciplinary team setting
• Basic understanding of statistical principles applied to the design and analysis of clinical trials
• Capable of contributing to the development of policies and making decisions regarding programming on company policies and procedures
• Strong problem solving skills
• Ability to supervise and mentor as shown by leadership of projects and team members
• Strong attention to detail
• Capable of facilitating communications with clients, project teams, departments and staff
• Awareness for project budget creation, including modifying for project updates
• Capable of managing project budgets and risks
• Strong understanding of clinical trials, ICH Statistical and reporting guidelines and GCP
• Delivery and quality driven