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Associate Director, Biostatistics
- United States - Illinois - Lake Forest
- United States - California - La Jolla
- United States - Washington – Bothell
- United States - New York - New York City
- United States - Pennsylvania - Collegeville
- United States - Massachusetts - Cambridge
- United States - Connecticut - Groton
- United States - California - South San Francisco
Full time
Posted 3 Days Ago
4919404
ROLE 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: Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; Regulatory and Health Technology Assessment (HTA) submissions; and 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.
ROLE 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 timeliness and quality of study/submission level statistical deliverables on assigned projects.
- 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 input to Statistics Program Lead and/or Statistics Therapeutic Area Head to plan support for assigned projects, studies, and submissions.
- 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, 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.
BASIC QUALIFICATIONS
- Advanced degree in statistics, biostatistics, or related field.
- A minimum of 4 years’ experience in the clinical trial setting (preferably in oncology of Pharma).
- 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 level.
- Strong statistical skills with application to clinical trials especially survival analysis methodology.
- Effective verbal and written communication skills.
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.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)