Senior Statistician - Epidemiology & Scientific Affairs

Pharmaceutical Product Development (PPD)

Bethesda, Maryland, United States of America

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

The Epidemiology & Strategic Affairs (ESA) Real-World Evidence (RWE) team within PPD combines epidemiology, outcomes research, biostatistics and statistical programming, and in order to support our clients in the pharmaceutical/ biotechnology/ medical device industries in building real-world evidence to demonstrate and support the clinical, economic and humanistic value of their products. We understand our clients’ needs and we support the design and conduct of real-world observational studies throughout the product development and lifecycle, from early pre-launch planning to launch and post-marketing management. Our passionate team works hard to address real-world research questions to help fill in the gaps of burden of disease and unmet needs, describe treatment patterns, drug utilization, and adherence, understand resource utilization and costs of care, identify risk factors on disease outcomes, and outline post-marketing effectiveness and safety through post-authorization safety studies and comparative effectiveness studies. We conceptualize sophisticated study designs and develop/oversee study documents such protocols, case report forms, statistical analysis plans, analysis interpretation and study reports.

Join our growing team of dedicated scientists where you will get to work on complex, engaging projects. Our focus is on advising our clients on their real-world evidence development plans, on de novo (field, primary) data collection studies such as single and multi-country retrospective chart reviews, surveys, prospective studies and registries, which are undertaken when existing healthcare databases cannot be used. Increasingly, hybrid studies that invoke the use of both secondary data sources with tailored data collection methods are deployed. We are constantly working on new and innovate solutions to address our clients’ needs. You would be joining a team of recognized industry guides who provide top methodological expertise and high levels of quality in a collaborative environment conducive to career growth. Whether you are looking to expand your knowledge and scientific skills or step into a leadership position, we are looking for a self-motivated, driven standout colleague who will thrive in this environment.

Position Location: North America, office-based, hybrid or 100% remote.

Discover Impactful Work:

The Senior Statistician provides statistical and programming expertise to the ESA Team through leadership in representing ESA statistical services, collaborations with other statistical teams across the organization, and project delivery, including Clinical Data Interchange Standards Consortium (CDISC) SDTM/ADaM standards as necessary, leading-development activities, business initiatives and long-term planning. This includes contributing to and driving -CDISC-based initiatives such as development of procedures, bidding templates, hiring, training and professional development.

When needed, the Senior Statistician will provide statistical as well as programming expertise. Responsibilities also include direct contributions to client proposals and study execution for the ESA business, including a variety of prospective and retrospective study designs. The Senior Statistician will be available to provide statistical consulting services across a variety of studies and study types and oversee and provide senior statistical review of statistical deliverables, as needed.

A day in the Life:
  • Contributes to ESA project delivery model under SDTM/ADaM standards
  • Assists in training of SDTM/ADaM standards to other statisticians and/or programmers
  • Contributes to the preparation of study proposals and statistical budgets. Independently organizes, leads, or participates in business development presentations and represents the practice area at bid defenses.
  • Acts as lead statistician, project lead, or programmer on ESA, consumer health and device projects and/or development programs
  • Translates client’s objectives and demands into quantitative workplans
  • Drives statistical and programming aspects of projects, including analysis plan writing, programming, and interpretation of the results in statistical methodology.
  • Methodological leadership in client meetings related to statistical methods and presentation of data analytics outputs and insights
  • Acts as statistical reviewer and provides first level of management communications and consultation with clients in a statistical sciences role
  • Helps to ensure best practices in methodological approaches to each study given the design and evidence needs for ESA, consumer health, and device trial designs
  • Develops training sessions, white papers, and presentations at conferences

Management – up to 25%
  • May manage staff, which may include interviewing and selection, job description preparation, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. May approve courses of action on salary administration, hiring, corrective action, and termination. May review and approve time record, expense reports, and requests for leave.
  • Contributes to the on-boarding and training of new ESA Statisticians and provides support for training and professional development opportunities. Works in collaboration with the Director, RWE Statistics, and Director of Learning and Development to ensure that training/onboarding documentation is current, accessible and disseminated, as appropriate, to ESA Statistics and programming.

Operational Statistical Support
  • Works with the ESA senior team members to identify and develop new approaches and processes to identify gaps and improve resource management, proposal development, project efficiency and quality involving analytics. Consults on existing and identifies areas where new SOPS are required.
  • Develops and provides consistent approaches to developing analysis budgets across different study designs.
  • Works with programming leads to develop processes, training and budget guidelines for CDISC SDTM/ADaM requirements.
  • Ensures adherence to departmental and company standard operating procedures (SOPs) and working practices (WPs). Contributes to their development as needed.

Collaboration
  • Operates effectively at the Practice and business area level, collaborating closely with senior staff in Data Analytics and Strategic and Scientific Affairs to find solutions to statistical challenges
  • Works closely with peers across the Practice Areas and across the broader PPD enterprise.

Project Work – 75% or more

  • Project Execution
  • Performs at the level of Statistical Expert in projects.

Keys to Success:

Education
  • PhD, MSc or BSc in Biostatistics, Statistics, or related field

Experience
  • Demonstrated experience
  • Management responsibility experience

Knowledge, Skills, Abilities
  • SAS (Base, Stat, Graph, Macro), R, SPSS, STATA, WinBUGS
  • Statistical expertise with work experience supporting a variety of study designs spanning clinical trials and observational research designs. Expert business knowledge with comprehensive understanding of the organization and functional areas
  • Expertise in project delivery using CDISC standards (CDASH, SDTM, ADaM)
  • Knowledgeable and experienced in serving as statistics expert in biopharma and/or medical device environment
  • Knowledgeable and experienced in understanding regulatory requirements and appropriate data standards, ability to provide recommendations to ensure project delivery is fit for purpose
  • Excellent management skills, including the ability to organize, plan and manage projects, create, and modify budgets, develop timelines, allocate resources, and forecast departmental workload.
  • Innovation and leadership in developing new ideas related to process improvements.
  • Strong analytical skills, strong knowledge of statistical principles, and strong statistical skills
  • Proven ability in supporting the development of new business opportunities
  • Knowledge in analytical SOPs or WPDs

Physical Requirements / Work Environment

We value 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 & 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.

Benefits

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.

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.

2023-05-23

Apply to this job