Candidates will be part of multi-disciplinary research teams to provide statistical expertise and methodological leadership at all stages of projects from planning to completion. Duties will vary according to the nature of the projects. The candidate will work with a senior scientist (e.g., epidemiologist, statisticians, programmer) and independently to contribute to the preparation of study protocols section, review study materials, developing statistical analysis plans, writing programs to execute analyses, and assisting with the interpretation and dissemination of findings. Additionally, the position involves development of Clinical Data Interchange Standards Consortium (CDISC) SDTM/ADaM standards, leading-development activities, business initiatives and long-term planning. This includes contributing to and executing -CDISC-based initiatives such as development of procedures, bidding templates, hiring, training and professional development. When needed, the Statistician will provide statistical as well as programming expertise. Responsibilities also include direct contributions to client proposals and study execution for the PPAS business, including a variety of prospective and retrospective study designs. The 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 PPAS 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 PPAS, consumer health and device projects and/or development programs
Translates client’s objectives and demands into quantitative workplans
Executes 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 PPAS, 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 PPAS Statisticians and provides support for training and professional development opportunities. Works in collaboration with the Director of RWE Statistics, and Director of Learning and Development to ensure that training/onboarding documentation is current, accessible and disseminated, as appropriate, to PPAS Statistics and programming.
Operational Statistical Support
Works with the PPAS 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.
Operates effectively at the Practice and business area level, collaborating closely with senior staff in PPAS, 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
Performs at the level of Statistical Expert in projects.
Keys to Success:
Education & Experience
PhD or MSc in Biostatistics, Statistics, or Related field with 7+ years of experience, or BSc in Statistics, Biostatistics or Related field with 15+ or more years of experience.
2+ years of management responsibility
Expert business knowledge with comprehensive understanding of the organization and functional areas
Advanced leadership skills
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
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
Expertise in project delivery using CDISC standards (CDASH, SDTM, ADaM)
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
Knowledge, Skills, Abilities
Highly developed interpersonal skills, problem solving, judgment and decision-making; driven, self-motivated and adaptable.
Excellent staff management skills; ability to identify and implement initiatives and change as needed
Strong collaborative skills – demonstrated ability to work and lead teams
Ability to work and adapt in a changing environment
Client focused - both internal and external
For more information and to apply, click 'Apply Here'.