Director, Biostatistics

Pfizer; Rochester Hills (MI); On-site; USD 242,000 - 322,000; Full time

Job summary

Pfizer is seeking a Director to plan, direct, and coordinate global development projects in Inflammation & Immunology & Specialty Care. You will oversee trial design, data management, and regulatory submissions, providing leadership in statistics and collaboration with diverse teams.

You will supervise biostatisticians as needed, supervise resource allocation, and stay current with statistical advances to drive strategic planning and methodological excellence.

Qualifications

• Master's or PhD in statistics/biostatistics with clinical trials experience.
• Understanding of clinical, regulatory and marketing processes.
• Ability to lead cross-functional statistical teams.
• Strong statistical skills applied to trials.
• Clear verbal and written communication with internal/external partners.
• Provide statistical support and oversight for multiple projects.
• Ability to perform complex data analysis and calculations.
• Proficiency in R, SAS or Python; experience with reproducible tools.

Responsibilities

• Provide rigorous statistical input into study design and regulatory submissions.
• Plan and communicate analyses, presentations, and scientific reports.
• Ensure timely, compliant statistics deliverables for projects.
• Collaborate with clinical teams, partner lines, and external groups.
• Lead cross-functional statistical activities for studies and submissions.
• Advise Statistics Group Lead on study support planning.
• Engage in research of innovative statistical methods for Pfizer.

Skills

Masters in Statistics/Biostatistics or

Clinical trials experience

Statistical leadership

Statistical analysis in trials

Excellent communication

Statistical support & oversight

Mathematical statistics calculations

Proficiency in R/SAS/Python

Education

Masters in Statistics/Biostatistics or PhD in Statistics/Biostatistics

Tools

R

SAS

Python

R Markdown

Job description

JOB SUMMARY

The Director will plan, direct, and coordinate specialized and complex global development projects within the Inflammation and Immunology & Specialty Care disease area at Pfizer Research and Development. The candidate’s accountabilities include overseeing clinical design, trial conduct, data management, result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and assisting in strategic planning. The position may require managing contract biostatisticians, including resource allocation, work assignment scheduling, and project status monitoring to ensure timely project completion. Staying informed on advancements in statistics and maintaining strong collaboration with various functional groups are essential. Excellent communication skills, proficiency in statistical programming languages (R, SAS or Python) and high motivation are crucial for success in this role.

JOB RESPONSIBILITIES

• Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects.
• Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results, exploratory analyses and analyses that synthesize results across studies, support for publication activities, scientific presentations and support for product defense.
• Be accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
• Develop effective collaborations with colleagues within clinical teams, partner lines of other functioning areas, and external regulatory, industry and professional and academic organizations.
• Provide statistical input and leadership to cross-functional activities - collaborate with other statisticians, study managers, alliance partner colleagues - for assigned studies and regulatory submissions.
• Provide input to the Statistics Group Lead (Senior Director or Executive Director) to plan support for assigned studies and submissions.
• Participate in research on innovative statistical methodology and its applications pertinent to Pfizer’s business needs.

QUALIFICATIONS / SKILLS

• Masters in Statistics/Biostatistics (or related field) with extensive experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with notable experience in clinical trials
• Relevant clinical trial 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 and project level.
• Strong statistical skills with application to clinical trials.
• Effective verbal and written communication skills in collaborating with colleagues and associates both inside and outside the organization.
• Providing statistical support and oversight for one or more clinical projects.
• Ability to perform mathematical and statistical calculations.
• Ability to perform complex data analysis.
• Proficiency in statistical programming languages (R, SAS or Python) and experience with at least one reproducible research tool (e.g., R Markdown, Quarto, Git/GitHub).

PREFERRED QUALIFICATIONS

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

RESOURCES MANAGED

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

ORGANIZATIONAL RELATIONSHIPS

As a key member of project team, this position will interact directly with Clinical (Clinicians), Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and Operations, Medical, Outcomes Research, Commercial, Operations and contract organizations supporting project deliverables.

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 is committed to celebrating this, in all its forms - 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.