ROLE SUMMARY
As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Group Lead is responsible for the collection, documentation and programming of study and asset level data cleaning and monitoring report requirements. The Group Lead works closely with the Program Lead (Reporting and Analytics) and CDS Therapeutic Area (TA) Leads to ensure the CDS team functions as a harmonized unit with consistent, timely and high quality application of process and delivery of CDS responsibilities. The Group Lead will also support CDS and Statistical Data Sciences & Analytics (SDSA) data deliverables from acquired companies. This role has additional line management responsibilities supporting development, system/technical processes, resources and colleague development. The Group Lead will also be accountable for the timely and high quality deliverables supporting the Pfizer portfolio.
ROLE RESPONSIBILITIES
Works closely with CDIS and SDSA department roles and cross-functional study team members to create reporting and analytics solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans.
Delivers data analysis reporting operational services to CD&O and other groups within Pfizer
Supports business reporting solutions for CD&O inclusive of presenting and communicating results that improve performance
Creates any needed documentation for reports throughout the lifespan of the study and or asset for all DMRA deliverables and ensures proper filing in the Trial Master File filings when appropriate.
Complies with applicable SOPs and work practices
Serves on the data standards board as needed and leads as needed implementation and where needed development of data management reporting standards.
Serve as a technical resource to the study teams for data visualization and reporting tools
Ensure operational excellence in collaboration with partners and colleagues for application of standards and develop data cleaning reports in support of the data review plan, in collaboration with the Clinical Data Scientist, ensure operational excellence across all CDIS and SDSA deliverables
Directly supports knowledge development of others on reporting and analytics tools that support the accuracy and integrity of study data
Identifies existing process/product improvements
Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
Takes appropriate risks to achieve desired results
Recognizes development needs and identifies/creates development opportunities within own team
Develops a talent base and anticipates development needs within the area of responsibility
BASIC QUALIFICATIONS
Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with 5 to 7 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency OR Masters or doctoral degree w Five or more years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)
Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable
Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills
Supervisory experience required with emphasis on managing employees remotely located
Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas
Technical skills and experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle), SAS and data visualization tools (e.g. Spotfire, jReview)
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
PREFERRED QUALIFICATIONS
Preference provided to those with programming, specifically SQL, Python and other visualization tools hands-on experience
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.
PHYSICAL/MENTAL REQUIREMENTS
Flexibility to accommodate different time zones within International Units
Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.
Work Location Assignment: Hybrid must be on site an average of 2.5 days per week.
The annual base salary for this position ranges from $120,800.00 to $201,400.00.* 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 | (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 $108,700.00 to $181,100.00.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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