Pfizer TA Head Vaccines Clinical Biostatistics and Nonclinical/Clinical Quantitative Modelling in Collegeville, Pennsylvania
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Head VaxSQM of Vaccine Clinical Research and Development (VCRD) must possess the ability to plan, direct and coordinate a large and expanding portfolio of specialized and complex Vaccine Research and Development (VRD) projects spanning phase 1 through phase 4 clinical development. The Head VaxSQM must have the broadest knowledge of clinical data management and statistical analysis tools and have the ability to interpret results from clinical, non-clinical, modelling and simulation, and epidemiologic studies. The Head VaxSQM should have ability to develop and roll out new initiatives and lead the VaxSQM group in strategic planning. He/she provides the highest level of data management, modeling, and statistical advice to VCRD and VRD leadership
The Head VaxSQM supervises the activities of Senior Directors directing the statisticians and modellers in Vaccines Clinical Research and at Functional Service Providers. The Head VaxSQM provides senior management review of protocols and CSRs, and is the senior representative to internal review comittees, DMC related company steering committees (etc.). The Head VaxSQM should be active in cross functional (TA) activities, in a consultative role, and providing the SVP of Clinical Research with more strategic advice as to the present and future direction for the VaxSQM group.
The Head VaxSQM should be a person of vision, should stay current on all new developments and technological advancement both in statistics and modelling areas. The Head VaxSQM should be a respected individual in his/her area of discipline; these qualities will have been obtained over the years by being innovative, active in publications, committee actives, presentations or other related activities. His/her expertise level should be such that he/she has the foresight of advising on the type of new training needed for the VaxSQM group (e.g., consulting and presentation skills).
The Head VaxSQM should be fully knowledgeable concerning the FDA, International Regulatory Agencies, and ICH guidelines and regulations applicable for the conduct, analysis and reporting of vaccine clinical trials. The Head VaxSQM should coach Senior Director and Director staff to enable them to engage in and provide quality input at regulatory interactions and with key opinion leaders. The Head VaxSQM is a strong advocate within Pfizer for VaxSQM's involvement taking a prominent role in the vaccine research &; development process.
Supervises statistical and modelling support activities. Evaluates the material generated by supervised staff including senior director reports for validity, quality, and effectiveness of presentation and coaches them in preparation for regulatory and KoL interactions.
Provide senior management statistical review of key documents (protocols, CSRs, regulatory briefings).
Be accountable for timely, production and accuracy of all statistical analyses and integrated scientific reports for clinical trial results, exploratory and Meta Analyses, publications activities, scientific presentation and promotional material on assigned studies and regulatory submissions both local and international.
Oversight of representation from VaxSQM in communicating statistical issues on studies to clinical, regulatory medical affairs, commercial teams, vaccine and Pfizer senior leadership. Be the company expert and resource on Vaccine statistical and modelling issues, by providing guidance to Clinical,Commercial, and Vaccine and Pfizer senior leadership. Identify, develop, and arrange for training on statistical issues (e.g., event driven trials).
Supervises hiring, performance appraisals, staff promotions, and other administrative functions.
Keeps informed of developments in new statistical/modelling methodology, and provides training to reports and VCRD.
Ph.D. or MS in Biostatistics, statistics, mathematics, computer sciences or other related field
Good oral and written communication required. Strong leadership and managerial skills required
Ph.D. with at least 20 years' experience and 15 years of supervisory activities
MS with 25 years of experience and 20 years of management experience
Documented experience in the pharmaceutical industry
Experience in Vaccine development is preferred.
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.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.