Manager, Statistics

Pfizer; Rochester Hills (MI); On-site; USD 94,000 - 148,000; Full time

Job summary

Pfizer is seeking an experienced statistician to design, analyze, and interpret clinical trials and observational studies in line with regulatory standards and Pfizer procedures. You will provide rigorous statistical expertise for development plans, HTA submissions, and publication efforts, guiding cross-functional teams across studies and submissions.

The role emphasizes leadership in study design, planning, and communication of results, with accountability for deliverables and adherence to

Qualifications

• Advanced degree in statistics, biostatistics, or related field.
• Relevant clinical trial, real-world data, and business experience providing understanding of clinical, regulatory, and marketing operations.
• Capability to provide statistical leadership to cross-functional teams at the protocol or project level.
• Strong statistical skills with application to clinical trials and/or analysis of observational studies.
• Effective verbal and written communication skills.

Responsibilities

• Provide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
• Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.
• Accountable for study or project level and submission level statistical deliverables on assigned projects.
• Accountable for implementation of quality, productivity, and other best practices.
• Develop effective collaborations internally and externally including, but not limited to, clinical teams, partner lines, regulatory, payer, industry, professional and academic organizations.
• Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
• Maintain compliance with all required training.
• Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or regulatory and HTA submissions.
• Provide to Statistics Group Lead and/or Head, Statistics input for planning support for assigned projects, studies, and submissions.
• Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
• Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.
• Communicate and collaborate with other project statisticians within R&D, or other organizations where applicable, to ensure consistency of statistical approaches across studies and alignment with approaches used in regulatory submissions.
• Present a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
• Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs.
• Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions.

Skills

Statistical leadership

Clinical trials

Regulatory submissions

Communication

Data analysis

Education

Advanced degree in statistics/ biostatistics

Job description

JOB SUMMARY

• Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices.
• Provide scientifically rigorous statistical expertise on: o Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; o Regulatory and Health Technology Assessment (HTA) submissions; and o Projects to maximize the value of aggregate clinical and real world data in support of drug development and other scientific strategies.
• Provide study and other project level statistical counsel and communicate resource needs to teams.

JOB RESPONSIBILITIES

• Provide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
• Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, support for publication activities, scientific presentations, and support to product defense.
• Accountable for study or project level and submission level statistical deliverables on assigned projects.
• Accountable for implementation of quality, productivity, and other best practices.
• Develop effective collaborations internally and externally including, but not limited to, clinical teams, partner lines, regulatory, payer, industry, professional and academic organizations.
• Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
• Maintain compliance with all required training.
• Provide statistical input and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or regulatory and HTA submissions.
• Provide to Statistics Group Lead and/or Head, Statistics input for planning support for assigned projects, studies, and submissions.
• Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies and projects.
• Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support processes that require statistical input.
• Communicate and collaborate with other project statisticians within R&D, or other organizations where applicable, to ensure consistency of statistical approaches across studies and alignment with approaches used in regulatory submissions.
• Present a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
• Participate in research on statistical methodology and its applications pertinent to the Pfizer business needs.
• Help maintain a strong statistics community at Pfizer through collaborations, scholarship, presentations, and learnings across divisions.

QUALIFICATIONS / SKILLS

• Advanced degree in statistics, biostatistics, or related field.
• Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations.
• Capability to provide statistical leadership to cross -functional teams at the protocol or project level.
• Strong statistical skills with application to clinical trials and/or analysis of observational studies.
• Effective verbal and written communication skills.

ORGANIZATIONAL RELATIONSHIPS

Reports to Statistics Group Lead or Head, Statistics

RESOURCES MANAGED

• Varies with career ladder level and project need--Statistics Leads may supervise the work of other statisticians.
• No direct budgetary responsibilities.

The closing deadline for applications is September 24th.

All applicants must have the relevant authorisation to live and work in the UK.

Purpose Breakthroughs that change patients' lives...

At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Medical Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives.

We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.