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PPD Senior Statistician - Peri- and Post Approval Studies (PPAS) in Bethesda, Maryland

SENIOR STATISTICIAN/LEAD STATISTICIAN - PPAS STATISTICS

*We are looking to fill this role in Bethesda, MD or Research Triangle Park, NC; however, we will consider remote based locations, depending on candidate’s experience.

Position Overview:

The Senior Statistician/Lead Statistician provides statistical and programming expertise to the PPAS Team through leadership in representing PPAS 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 executing -CDISC-based initiatives such as development of procedures, bidding templates, hiring, training and professional development.

When needed, the Senior Statistician/Lead 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 Senior Statistician/Lead 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.

Essential Duties and Responsibilities (other duties may be assigned):

  • Contribute to PPAS project delivery model under SDTM/ADaM standards

  • Assist in training of SDTM/ADaM standards to other statisticians and/or programmers

  • Contribute 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.

  • Act as lead statistician, project lead, or programmer on PPAS, consumer health and device projects and/or development programs

  • Translate client’s objectives and demands into quantitative workplans

  • Execute 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 provide first level of management communications and consultation with clients in a statistical sciences role

  • 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 reviews and approves 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.

  • Work with programming leads to develop processes, training and budget guidelines for CDISC SDTM/ADaM requirements.

  • Collaboration

  • 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

  • Project Execution

  • Performs at the level of Statistical Expert in projects.

    Education, Professional Skills & 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

    Personal Skills & Competencies:

  • 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.

  • Excellent staff management skills; ability to identify and implement initiatives and change as needed

  • Strong collaborative skills – demonstrated ability to work and lead teams

  • Client focused - both internal and external

  • 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

    About Evidera:

    Evidera is a business within in Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.

    Perks:

    We offer a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.

    Evidera’s Core Competencies:

  • Customer Focus

  • Initiative

  • Teamwork

  • Problem Solving/Judgment

  • Accountability

    If you resonate with our core competencies and want to contribute to research and consulting services driven by world-class science and thought leadership, then please submit your application – we’d love to hear from you.

    Evidera, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, sexual orientation, gender preference, disability, or status as a qualified individual with a disability or protected veteran.

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