Associate Director, Biostatistics

2 weeks ago

Cambridge, United States Pfizer Full time

WHY PATIENTS NEED YOU

This position will provide statistical support for projects in the Inflammation and Immunology disease area in Global Product Development. You will collaborate and work closely with project or study teams and provide 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. You may also provide support in regulatory submissions including responses to regulatory queries. You will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies.

KEY RESPONSIBILITIES- Provide scientifically rigorous statistical input into project development plans, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans and scientific and commercialization projects.- Be accountable for study level and submission level statistical deliverables on assigned projects, including timeliness and quality of deliverables according to project plans.- Develop effective collaborations with others within clinical teams, partner lines (such as, Development Operations, Pharmaceutical Sciences, Safety Risk Management, Regulatory), and external regulatory, industry, professional and academic organizations.- 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 statistical input and leadership to cross-functional activities - collaborate with other statisticians, study managers, programmers - for assigned studies and regulatory submissions- Provide input to the Statistics Group Lead to plan support for assigned studies and submissions.- Communicate and collaborate with other project statisticians within the unit to ensure consistency of statistical approaches across studies and alignment with approaches used in phase III regulatory submissions.- 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 collaborations, scholarship, presentations and learnings across divisions and locations.

MINIMUM QUALIFICATIONS- MS in Statistics/Biostatistics or related field with 8+ years’ experience or PhD in Statistics/Biostatistics or related field with 5+ years' experience in clinical trials-
- Experience with SAS or R programming languages- Effectively and clearly explaining statistical concepts to colleagues without statistical training

PREFERRED QUALIIFICATIONS- Strong computational skills- Experience with different study designs, protocol development, and statistical analysis plan writing- Experience with statistical modelling of clinical data and statistical inference

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.

Work Location Assignment: Flexible

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 applicant

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