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.

Location/Division Specific Information

This position offers 100% remote working flexiblity in Europe.

Discover Impactful Work:

We are seeking a highly experienced and motivated Clinical Trials Lead Programmer to join our dynamic team. In this role, you will be responsible for overseeing the statistical and programming aspects of multiple projects, acting as the lead programmer, project lead, or project oversight lead for a client/asset. You will play a crucial role in the design, analysis, and reporting of clinical trials, ensuring adherence to regulatory requirements and industry standards. Additionally, you will represent the department to clients, actively contributing to proposals and bids, and organizing teams to implement study strategies and ensure process and programming efficiencies. This position may also involve managing a small team within the programming group.

A day in the Life: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 tasksInteracts 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 issuesKeys to Success:EducationMS/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 requirementsExperiencePreferred is at least 6 years of clinical trial experience as a statistical programmer and at least 1 year of leadership experienceIn 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.Knowledge, Skills, AbilitiesProgramming 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 languagesExpert level knowledge and highly resourceful hands-on experiences in SDTMS/ADaMs /TLFs specifications and programmingGood Knowledge of Pinnacle 21Strong SAS programming skills and understanding of database structuresStrong organizational skills across individual projectsCapable of independently and effectively organizing and managing own and team work loads, and completing multiple assignments with challenging timelinesAbility to adapt and adjust to changing prioritiesExcellent written and verbal communication skills, including proficiency in the English languageCapable of working in a multi-disciplinary team settingBasic understanding of statistical principles applied to the design and analysis of clinical trialsCapable of contributing to the development of policies and making decisions regarding programming on company policies and proceduresStrong problem solving skillsAbility to supervise and mentor as shown by leadership of projects and team membersStrong attention to detailCapable of facilitating communications with clients, project teams, departments and staffAwareness for project budget creation, including modifying for project updatesCapable of managing project budgets and risksStrong understanding of clinical trials, ICH Statistical and reporting guidelines and GCPDelivery and quality drivenBenefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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