Manager Biostatistics

Pfizer

5+ years

Not Disclosed

Remote, USA

10 Nov. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Why Patients Need You

At Pfizer, our mission is to deliver breakthroughs that transform patients’ lives. Research and Development is at the core of this mission, where we focus on translating cutting-edge science and technology into the medicines and vaccines that matter most. From drug safety and efficacy to supporting clinical trials, we apply the latest design and process development capabilities to accelerate the delivery of life-changing medicines globally.

Our Worldwide Medical and Safety colleagues play a critical role in providing evidence-based, medically necessary expertise, helping inform healthcare decisions on the safe and appropriate use of medicines.

What You Will Achieve

Pfizer's Non-Clinical Statistics team is looking for a motivated statistician with experience in nonclinical statistics, strong consulting skills, and a passion for collaborating with drug discovery and development scientists. You will work closely with research scientists in multiple therapeutic areas to support the design and analysis of preclinical experiments, covering target identification, pharmacology studies, animal models, biomarker development, and proof of concept. You will contribute to both “platform” approaches (e.g., ensuring robust assay methods) and specific project strategies, while engaging in statistical consultation to support drug target biology research.

How You Will Achieve It

Collaborate with vaccine assay specialists to develop, qualify, and validate clinical and diagnostic assays.
Work closely with preclinical scientists to support vaccine development efforts.
Ensure statistical rigor and adherence to scientific best practices in protocols, analysis plans, and manuscripts.
Provide statistical expertise for regulatory submissions, ensuring high-quality deliverables.
Bring innovative statistical approaches to enhance data analysis and decision-making in vaccine development.
Contribute to the standardization of processes and methodologies, including developing tools to support analysis.
Prepare and present internal and external reports to improve decision-making and increase external influence.

Qualifications

Must-Have

Master's degree in Statistics/Biostatistics.
At least 3+ years of pharmaceutical experience, with some preclinical/non-clinical experience.
Proficiency in statistical design of experiments, assay development, and applications in preclinical research.
Knowledge of regulatory requirements in drug development statistical analysis.
Strong experience with general linear models, mixed models, non-linear models, experimental design, variance components, and quality control.
Computational proficiency in R and SAS.
Experience collaborating with non-statisticians and research scientists.

Nice-to-Have

PhD in Statistics/Biostatistics or a related field.
Experience in assay validation, particularly clinical assays.
Background in vaccine development.
Ability to create computational tools for data visualization.
Strong communication skills and experience working in teams.

Physical/Mental Requirements

Ability to perform mathematical calculations and complex data analysis.

Relocation support available

Work Location: Hybrid

The annual base salary for this position ranges from $99,900.00 to $166,500.00, with eligibility for Pfizer’s Global Performance Plan (bonus target of 15% of base salary) and participation in the company’s long-term incentive program. Benefits include a 401(k) plan with matching contributions, paid time off, health benefits (medical, prescription drug, dental, and vision), and more.

Sunshine Act
Pfizer reports payments and transfers of value to healthcare providers as per federal and state transparency laws. Payments made to licensed physicians as part of recruiting expenses may be disclosed.

EEO & Employment Eligibility
Pfizer is an Equal Opportunity Employer, committed to diversity and inclusion, and complies with all applicable laws regarding nondiscrimination and employment eligibility verification. This position requires permanent work authorization in the United States.

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Manager Biostatistics

Job Description

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