Director, Biostatistics

Pfizer; New York (NY); Hybrid; USD 169,000 - 283,000; Full time

Job summary

Pfizer is looking for a Director of Biostatistics to lead complex global development projects in Non-Malignant Hematology. The role encompasses managing clinical trials, providing statistical support, and ensuring project compliance while driving innovative solutions within the Inflammation and Immunology disease area.

Benefits

401(k) with matching contributions

Paid vacation and personal days

Health benefits (medical, dental, vision)

Comprehensive life coverage

Paid caregiver leave

Qualifications

• 10+ years' experience in clinical trials with a Master's or 7+ years with a PhD.
• Experience in clinical trial processes and regulatory understanding.
• Proficient in statistical programming languages and reproducible research tools.

Responsibilities

• Oversee clinical design, trial conduct, and data management.
• Provide statistical input for regulatory submissions and project development.
• Collaborate with cross-functional teams on study and submission deliverables.

Skills

Statistical leadership

Communication

Programming (R, SAS, Python)

Data analysis

Education

Masters in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

R

SAS

Python

R Markdown

Git/GitHub

Job description

locations United States - New York - New York City United States - Pennsylvania - Collegeville United States - Massachusetts - Cambridge United States - Connecticut - Groton

time type Full time

posted on Posted 3 Days Ago

job requisition id 4937035

JOB SUMMARY

The Director of Biostatistics will plan, direct, and coordinate specialized and complex global development projects of Non-Malignant Hematology 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 to plan support for assigned studies and submissions.
• Participate in research on innovative statistical methodology and its applications pertinent to Pfizer’s business needs.

BASIC QUALIFICATIONS

• Masters in Statistics/Biostatistics (or related field) with 10+ years' experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 7+ years' 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).
• 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.

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, Operationsand contract organizations supporting project deliverables.

Work Location Assignment:Hybrid

#LI-PFE

The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits |

JOB SUMMARY

The Director of Biostatistics will plan, direct, and coordinate specialized and complex global development projects of Non-Malignant Hematology 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 to plan support for assigned studies and submissions.
• Participate in research on innovative statistical methodology and its applications pertinent to Pfizer’s business needs.

BASIC QUALIFICATIONS

• Masters in Statistics/Biostatistics (or related field) with 10+ years' experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 7+ years' 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).
• 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.

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, Operationsand contract organizations supporting project deliverables.

Work Location Assignment:Hybrid

#LI-PFE

The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.

Medical#LI-PFE