Director, RWE Statistics - Strategic & Scientific Affairs
Pharmaceutical Product Development, Inc.
DIRECTOR STATISTICS - STRATEGIC & SCIENTIFIC AFFAIRS *We are looking to fill this role in North America or EMEA.The Real-World Evidence team supports biopharmaceutical companies throughout the product lifecycle, from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries build economic and epidemiological evidence to demonstrate and support the value of their products. Through analysis of large health administrative databases (e.g., medical claims, electronic health records, registries, etc.), we may provide key information such as:Treatment patterns and drug utilizationResource utilizationThe incidence and prevalence of diseases and co-morbiditieThe incidence of adverse eventThe impact of various risk factorCost-effectiveneBurden of diseaseComparative effectiveness dataPosition Overview:The Director provides operational leadership and oversees operational excellence for both the statistician and statistical programming functions within the department. Ensures systems are in place to produce quality work efficiently, allowing for growth. Directs the development and implementation of Standard Operating Procedures and Working Practice Documents. Provides extensive input to leadership team to identify and address critical needs and develop strategic initiatives. Leads process improvement and implements standards. Consults with project teams, sponsors, and other clients/agencies on project-related issues. Represents PPAS on statistical and programming expertise in, collaborations with other statistical teams across the organization. The Director will be available to provide statistical expert oversight contributions to offering development, client proposals and study execution through senior statistical review of statistical deliverables for the PPAS business, including a variety of prospective and retrospective study designs.Essential Duties and Responsibilities (other duties may be assigned): Standardizes processes within the biostatistics and statistical programming functional areas. Evaluates and supervises the development of new tools and technology that would increase efficiency and accuracy within department. Serve as expert and develop PPAS-RWE project delivery model Informs senior leaders of team activities, accomplishments, and needs Participates in long-range strategic planning and development of departmental business plan Independently organizes, leads, or anticipates in business development presentations and represents the practice area at bid defenses Oversees statistical contributions to study proposals, bids for statistical budgets Communicates company and department policies and priorities to team and assures compliance Ensures appropriate personnel resources are applied to PPAS-RWE projects based on priorities and relative complexity Provides statistical consultation and serves as senior statistical reviewer on projects. Reviews and/or approves documents related to project activities. Plans strategically, develops department initiatives, and implements plans. Coordinates objectives and direction for statistical and programming services for the department. Senior oversight of team to ensure best practices in methodological approaches to each study given the design and evidence needs, particularly PPAS, consumer health, and device trial designs Overseeing the work and development of junior statisticiansManagement - up to 20% 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. Directs the on-boarding and training of new PPAS statisticians and programmers, provides support for training and professional development opportunities.Works in collaboration with the Director of Learning and Development to ensure that training/onboarding documentation is current, accessible, and disseminated, as appropriate, to PPAS biometrics.Operational Leadership - up to 50% 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. Work with programming leads to develop processes, training and budget guidelines Ensures adherence to departmental and company standard operating procedures (SOPs) and working practices (WPs).Contributes to their development as needed.Collaboration - up to 25% Operates effectively as a senior leader 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 Execution - up to 5% Performs at the level of Senior Statistical Oversight in projects.Qualifications:Education, Professional Skills & Experience: PhD or MSc in Biostatistics, Statistics, or Related field with 10+ years of experience, or BSc in Statistics, Biostatisics or Related field with 12+ years of experience. 3+ 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, WinBUGSPersonal Skills & Competencies: 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, leading statistical contributions for programs of research from end to end Knowledgeable and experienced in understanding regulatory requirements and appropriate data standards, ability to provide recommendations to ensure project delivery is fit for purpose Ability to identify gaps in current processes, develop/update current processes and training requirements to ensure all deliverables are of the highest quality 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. 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; demonstrated success in developing and executing processes through cross practice collaborations Ability to work and adapt in a changing environment 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 Proficiency in writing analytical SOPs or WPDsWho we are?Evidera is a business within 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.Working Environment: PPD 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 & 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.What we offer?We know that if you are provided with the right support and resources needed you will thrive! Therefore, Evidera offers a great mix of compensation and benefits options to show you how valuable you are to the organization.Some of our perks include: Highly competitive salary and bonus structure Generous benefits package, including healthcare, dental, vision and paid time off to spent with your friends and family Flexible working environment by offering fully remote work for most of our positions, to support work-life balance Clear opportunities for growth and career progression. We offer multiple Learning & Development programs, coaching and mentoring trainings, career planning and discussions to help you grow as a professional. Access to Employee Well-being programs and services. We value your emotional health and offer a variety of programs to support your mental healthcare. Collaborative working environment with focus on Diversity and Inclusion. At Evidera, we respect one another and recognize that our diversity makes our business stronger. We strive to be an inclusive organization where colleagues can be their authentic selves and grow their careers. Global exposure: Opportunity to work on multiple projects with some of the industry's leading researchers around the globe. Smooth onboarding process with your own dedicated onboarding specialist and a working buddy to help you navigate through your first few weeks thus ensuring great start to your new role.Our 4i Values:Our 4i Values are critical components in accomplishing our mission. These values guide us and, ultimately, define us.Integrity - Innovation - Intensity - Involvement If you resonate with them and wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!**only shortlisted candidates will be contacted#LI-REMOTE