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Clinical Statistician, Associate Director

Pfizer, S.A. de C.V
Cambridge
1 month ago
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  • United States - Massachusetts - Cambridge
  • United States - Connecticut - Groton
  • United States - Pennsylvania - Collegeville
  • United States - New York - New York City

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – 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.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

This position provides statistical support for clinical and scientific projects led by the Rheumatology group within the Inflammation and Immunology & Specialty Care disease area at Pfizer Research and Development. The successful candidate will collaborate closely with cross-functional project and study teams, offering statistical expertise in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful candidate will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies. Proficiency in at least one statistical programming language (R, SAS, or Python) is required.

JOB RESPONSIBILITIES

  • Provide scientifically rigorous statistical input into project development plans, regulatory submissions, interpretation of statistical results, study design, statistical analysis plans and scientific and commercialization projects.
  • Be accountable for quality statistical deliverables according to study and submission timelines.
  • Develop effective communication and collaborations with clinical teams, partner lines, and external organizations. Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, programmers – for assigned studies and regulatory submissions.
  • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modeling and simulation in support of various activities, support for publications, scientific presentations, and support to product defense.
  • Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
  • Help maintain a strong statistics community at Pfizer through research collaborations, scholarship, presentations and learnings across divisions and locations.

QUALIFICATIONS / SKILLS

BASIC QUALIFICATIONS

  • Masters in Statistics/Biostatistics (or related field) with 8+ years' experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 4+ years' experience in clinical trials
  • Effective verbal and written communication skills
  • Understanding of broad statistical theory and its application
  • Proficiency in at least one statistical programming language (R, SAS, or Python)
  • Experience with at least one reproducible research tool (e.g. R Markdown, Quarto, Git/GitHub)
  • Effectively and clearly explaining statistical concepts to colleagues without statistical training
  • Work collaboratively as a team member
  • Experience with statistical modelling of clinical data and statistical inference

Preferred qualifications

  • Strong computational skills
  • Experience with different study designs, protocol development, and statistical analysis plan writing
  • Experience or familiarity with large language models (LLMs) and their application in clinical settings is a plus

ORGANIZATIONAL RELATIONSHIPS e.

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

Location: Hybrid

#LI-PFE

The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.

JOB SUMMARY

This position provides statistical support for clinical and scientific projects led by the Rheumatology group within the Inflammation and Immunology & Specialty Care disease area at Pfizer Research and Development. The successful candidate will collaborate closely with cross-functional project and study teams, offering statistical expertise in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful candidate will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies. Proficiency in at least one statistical programming language (R, SAS, or Python) is required.

JOB RESPONSIBILITIES

  • Provide scientifically rigorous statistical input into project development plans, regulatory submissions, interpretation of statistical results, study design, statistical analysis plans and scientific and commercialization projects.
  • Be accountable for quality statistical deliverables according to study and submission timelines.
  • Develop effective communication and collaborations with clinical teams, partner lines, and external organizations. Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, programmers – for assigned studies and regulatory submissions.
  • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modeling and simulation in support of various activities, support for publications, scientific presentations, and support to product defense.
  • Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
  • Help maintain a strong statistics community at Pfizer through research collaborations, scholarship, presentations and learnings across divisions and locations.

QUALIFICATIONS / SKILLS

BASIC QUALIFICATIONS

  • Masters in Statistics/Biostatistics (or related field) with 8+ years' experience in clinical trials, or PhD in Statistics/Biostatistics (or related field) with 4+ years' experience in clinical trials
  • Effective verbal and written communication skills
  • Understanding of broad statistical theory and its application
  • Proficiency in at least one statistical programming language (R, SAS, or Python)
  • Experience with at least one reproducible research tool (e.g. R Markdown, Quarto, Git/GitHub)
  • Effectively and clearly explaining statistical concepts to colleagues without statistical training
  • Work collaboratively as a team member
  • Experience with statistical modelling of clinical data and statistical inference

Preferred qualifications

  • Strong computational skills
  • Experience with different study designs, protocol development, and statistical analysis plan writing
  • Experience or familiarity with large language models (LLMs) and their application in clinical settings is a plus

ORGANIZATIONAL RELATIONSHIPS e.

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

Location: Hybrid

#LI-PFE

The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Medical#LI-PFE
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