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AD Programming

Pharmaceutical Product Development (PPD)

Multiple locations

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.  

What the role does: 

Senior management position over programming managers and programming staff within the Department of Biostatistics. Coordinates the development and implementation of Standard Operating Procedures and Working Practice Documents. Interacts extensively with a multi-disciplinary senior management team to identify critical needs and develop strategic initiatives  

Does that sound like you? These are some of the main activities the role includes: 

  • Understand and follow department’s working practice documents and SOPs, and contribute to their development as needed.  

  • Understand and follow appropriate corporate SOPs.  

  • Participate in client contract negotiations when modifications are required.  

  • Participate in senior management meetings and be an active participant in long range department planning.  

  • Interact with business development and visit client sites in an effort to develop client relationships for current and future projects.  

  • Increase knowledge base and professional skills of staff in areas including programming technology and techniques, clinical trials, and the pharmaceutical industry through on the job training, mentoring, and internal or external training courses.  

  • Manage and participate in the development of training material and standard processes to facilitate resource sharing and consistency across PPD locations.  

  • Work with staff to develop short term and long term career development goals.  

  • Actively recruit new staff commiserate with business needs.  

  • Work to increase the visibility of PPD, Inc. by encouraging the publications of articles in industry journals and presentations at conferences.  

  • Provide mentoring, leadership and supervision to staff.  

  • Monitor staff assignments, evaluating and shifting priorities and assignments to meet timelines and deliver high quality work. Provide feedback to management when timeline or resourcing constraints develop. 

  • Ensure adherence to all SOPs and working practices.  

  • Participate in divisional decision making including bid preparation, and marketing activities.  

  • Responsible for acting as a liason between other divisions within the company and with the client.  

  • Responsible for keeping the director of Biostatistics, Programming and Data Management informed of team activities, accomplishments and needs.  

  • Responsible for participating in long range department planning.  

  • Be familiar with any relevant contractual obligations or limits with our clients.  

  • Work directly with project team leaders and client representatives to assess and develop project goals and timelines.  

  • Communicate actively and frequently with other team members as needed.  

  • Demonstrate a good understanding of the role of the programmer in the overall process.  

  • Assume leadership responsibilities as a member of a multi-disciplinary project team. 

  •  Manage the creation, execution, maintenance, and validation of programs that transfer data across multiple data management systems or operating systems, combine data from a variety of sources and structures, generate and store summary data from a variety of sources, generate reports or combine multiple databases.  

  • Manage the creation, execution, maintenance, and validation of programs that generate listings, tables and figures using SAS, PL/SQL, or other appropriate languages.  

  •  Supervise and perform project management tasks as necessary to support Clinical Data Management and Biostatistics.  

  • Provide general infrastructure support to the Biostatistics Department. Examples include giving presentations at Department meetings, and contributing to other department documents or policies.  

Education 

  • MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 8 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 10 years of experience that provides the knowledge, skills, and abilities to perform the job requirements 

  • Preferred is at least 9 years of clinical trial experience as a statistical programmer and at least 5 years 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. 

Knowledge, Skills, Abilities 

  • Experience in managing and developing staff and their career objectives including the ability to motivate and inspire staff. 

  • Ability to train, supervise and mentor others.  

  • Ability to facilitate communications with clients, project teams, departments and staff.  

  • Ability to assist business development in the process of obtaining new clients and retaining existing clients.  

  • Ability to make decisions on company policies and procedures regarding programming.  

  • Understand and track project budgets.  

  • Understand and participate in bidding programming work.  

  • Demonstrate leadership and problem solving capability.  

  • Proficient in one or more programming languages and have strong technical skills.  

  • Knowledge of clinical trials.  

  • Thorough understanding of company processes particularly in Data Management and Biostatistics.  

  • Understanding of relational data base structure and experience working with complex data systems.  

  • Experience demonstrating a strong attention to detail.  

  • Experience demonstrating leadership ability and ability to work on a multi-disciplinary project team.  

  • Excellent problem solving skills.  

  • Excellent written and verbal communications skills.  

  • Ability to independently and effectively organize and manage multiple assignments with challenging timelines.  

  • Ability to adapt and adjust to changing priorities.  

  • Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.  

  • Demonstrated leadership, initiative and motivation.  

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.  

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. 

Accessibility/Disability Access 

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. 

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. 

Job posted: 2023-03-21

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