Programming Mgr

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. Discover Impactful Work: Manages a team within the department who are responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Able to act as the lead statistician, project lead, or senior reviewer on select projects. Contributes to study proposals and bids, representing the department at bid defenses. Organizes teams and implements strategies to ensure smooth operation and project financial success. A day in the Life: - Manages staff, 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. Ensures effective resource and utilization management of staff. - Acts as lead statistician, project lead, or senior reviewer on multiple projcts, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation. - Serves as the randomization statistician on selected projects. Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Reviews protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections. - Prepares and reviews statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. Contributes statistical methods section for integrated clinical statistical reports. Reviews integrated clinical statistical reports. - Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management. - Aids departmental management in process-improvement strategies. Suggests, assesses, and provides leadership in the department for such initiatives. Education: - Masters degree in statistics, biostatistics, mathematics or related field Experience: - Masters degree in statistics, biostatistics, mathematics or related field with 6+ years experience, preferring at least 7 years of clinical trial experience as a statistician Previous experience that provides the knowledge, skills, and abilities to perform the job - 2+ yrs of management responsibility - 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 and Abilities: - Demonstrated initiative and motivation - Capable of leading complex projects - Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff - Strong verbal and written communication skills - , including proficiency inthe English language - Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting - Strong knowledge of SAS® and clinical biostatistics - Strong understanding of the drug development process and FDA regulations - Capable of managing change and uncertainty to optimize positive outcomes Work Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: - Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. - Able to work upright and stationary for typical working hours. - Ability to use and learn standard office equipment and technology with proficiency. - Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. - May require travel. (Recruiter will provide more details.) 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. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. 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