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Program Lead (Director, Data Management)


Collegeville, PA 19426
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Job Details


As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Management Reporting and Analytics Director is responsible for overseeing the collection, documentation and programming of study and asset level data cleaning and monitoring report requirements. The Data Management Reporting and Analytics Director will be accountable for the timely and high quality development and delivery of reporting solutions supporting the Pfizer portfolio.


+ Leads the Data Management Reporting and Analytics (DMRA) group inclusive of the recruitment, performance and development of people

+ Works closely with department and cross-functional leadership to establish strategy, timelines, and resourcing of data management reporting and analytics deliverables

+ Accountable for the resource forecasting and solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans

+ Ensures appropriate documentation across the lifespan of the study and asset for all DMRA deliverables and verifies proper Trial Master File filings when appropriate

+ Ensures compliance with applicable SOPs and work practices

+ Serves on the data standards board and leads as needed implementation and where needed development of data management reporting standards

+ Provides technical input and coaching to direct reports to ensure the development of skills with DMRA and the broader data monitoring and management community

+ Investigates/brings in tools and technology to enable reporting and analytics to follow evolving science/business needs: smart listings, visuals, histograms, etc.

+ Using reporting and analytics to streamline /influence process and performance for DMM/consumers - ultimately helping DMM achieve DQ and integrity


+ Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with 10 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency OR Masters or doctoral degree with 7 or more years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

+ Thorough 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.)

+ Thorough 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

+ Preference provided to those with programming, specifically SAS and other visualization tools hands-on experience

**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.

**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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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