- 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.
- 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 and locations.
- 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
- Understanding of broad statistical theory and its application
- Experience with SAS or R programming languages
- Effectively and clearly explaining statistical concepts to colleagues without statistical training
- 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
- 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.
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Pfizer: Associate Director, Biostatistics - Cambridge, United States - AAAS
Description
WHY PATIENTS NEED YOU
Pfizer's purpose is to deliver breakthroughs that change patients' lives.
Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most.
Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
POSITION SUMMARY
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
MINIMUM QUALIFICATIONS
PREFERRED QUALIIFICATIONS
ORGANIZATIONAL RELATIONSHIPS
Candidate must demonstrate 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.
Work Location Assignment:
Flexible
The annual base salary for this position ranges from $131,200.00 to $218, 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 | ). 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
