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Pfizer, S.A. de C.V

Manager, Clinical Data Scientist, Clinical Data Sciences

Pfizer, S.A. de C.V, Oklahoma City, Oklahoma, United States,


Manager, Clinical Data Scientist, Clinical Data Sciences

United States - Washington – BothellUnited States - New York - Pearl RiverUnited States - New York - New York CityUnited States - Pennsylvania - CollegevilleUnited States - Massachusetts - CambridgeUnited States - Connecticut - GrotonWe’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.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 SUMMARYAs part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. The CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.KEY RESPONSIBILITIESServe as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligenceServe as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reportingPartners with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned.Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).Ensure work carried out by or on behalf of CDS is in accordance with applicable SOPs and working practices.Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed

contemporaneously.Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.MINIMUM QUALIFICATIONSDemonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO settingWorking knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol reviewStrong Project and Risk ManagementCRO and vendor oversight experience preferredMinimum 5 years Data Management experience requiredWorking knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirementsProficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / Inform preferred)Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)Familiarity with

MedDRA/WHO-DrugBachelor’s degree required. Degree in scientific field preferred.PREFERRED QUALIFICATIONSPHYSICAL/MENTAL REQUIREMENTSPrimarily an office-based position involving sitting, walking to meetings, making presentations, etc.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSAbility to travel approximately 5 to 10%Work Location Assignment: HybridWHY PATIENTS NEED YOUPfizer’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 SUMMARYAs part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. The CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.KEY RESPONSIBILITIESServe as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence

Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting

Partners with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned.

Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).

Ensure work carried out by or on behalf of CDS is in accordance with applicable SOPs and working practices.

Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.

Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed

contemporaneously.

Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.

MINIMUM QUALIFICATIONSDemonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting

Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review

Strong Project and Risk Management

CRO and vendor oversight experience preferred

Minimum 5 years Data Management experience required

Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / Inform preferred)

Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)

Familiarity with

MedDRA/WHO-Drug

Bachelor’s degree required. Degree in scientific field preferred.

PREFERRED QUALIFICATIONSMaster’s degree preferred.

PHYSICAL/MENTAL REQUIREMENTSPrimarily an office-based position involving sitting, walking to meetings, making presentations, etc.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSAbility to travel approximately 5 to 10%

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $93,500.00 to $155,900.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% 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 | (uscandidates.mypfizerbenefits.com). 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.* The annual base salary for this position in Tampa, FL ranges from $84,200.00 to $140,400.00. Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer 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 EligibilityPfizer 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.MedicalBreakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:“Breakthroughs”

- These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.“Change”

- We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.“Patients’ lives”

- We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.Our Values

To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.Courage:

Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.Excellence:

We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.Equity:

We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.Joy:

We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.Our Competitive Benefits Programs help our colleagues by:Promoting Health and Wellness

to help colleagues maintain and improve their physical and mental

wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness

counseling

and more.Strengthening Colleagues’ Financial Security

by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.Providing Benefits and Time off for the Moments that Matter

to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.And so much more , depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness

centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.

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