Senior Manager Biostatistics
MAIN RESPONSIBILITIES / DUTIES
Lead the development and championing of techniques based on state-of-the-art statistical research and seek creative solutions through collaborations and interactions with other experts in vaccines field. Provide statistical advice and guidance to Pfizer Vaccines Medical to enable optimal decisions in various vaccine programs.
Provide scientifically rigorous statistical input and leadership into clinical development plans, protocol development, regulatory submissions and questions, interpretation of statistical results, study design, and other product support projects.
Collaborate with clinicians, programmers, data managers, other statisticians, study managers, other MDSCA colleagues for assigned studies and regulatory submissions to ensure quality deliverables.
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, support for publication activities, scientific presentations, and support to product defense.
Be up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the assigned curriculum
Communicate and collaborate with other project statisticians within Pfizer to ensure consistency of statistical approaches across studies and alignment with approaches used in epidemiological studies and regulatory submissions.
Help maintain a strong statistics community at Pfizer through collaborations, presentations and learnings across divisions and locations.
Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will design, plan and execute biostatistical components of plans for research and development projects. This will assist in establishing the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and biological products.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will achieve objectives, interpret internal and external business challenges and recommend best practices for improvements.
It is your commitment and hard work that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Develop ideas, lead/co-lead complex projects across business units and develop plans to achieve objectives.
Serve as a resource to consult with project statisticians and statistics heads in establishing consistent global systems and processes.
Support planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results and support for publication activities.
Participate in professional development activities both within and outside the company.
7+ years' experience
Demonstrated experience and success providing timely and quality statistical contributions and scientific reporting of clinical trials for regulatory submissions
Knowledge of experimental design
Strong understanding of the state-of-the-art technologies to evaluate and leverage them for improved business processes
Aptitude to identify, understand, and apply relevant scientific literature
Demonstrated strong written and verbal communication skills
Relevant pharmaceutical industry experience
Ability to write comprehensive statistical analysis programs, as well as statistical section of complex research protocols; must be able to perform complex mathematical calculations and have the ability to perform complex data analyses.
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.