Senior Associate, Senior Reporting Analyst

Year    Chennai, Tamil Nadu, India

Job Description


ROLE SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Senior Reporting Analyst has responsibilities for the collection, documentation and programming of study and asset level data cleaning and monitoring report requirements. The Senior Reporting Analyst will have responsibilities for the timely and high quality development and delivery of reporting solutions supporting the Pfizer portfolio.

ROLE RESPONSIBILITIES

Creates reporting and analytics solutions with appropriate oversight that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans

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 as a technical resource to the study teams for data visualization and reporting tool

Collaborates with other analysts, Clinical Data Scientists and other roles as needed to apply standards and to develop data cleaning reports to support of the data review plan

Supports knowledge development of others on reporting and analytics tools that support the accuracy and integrity of study data

QUALIFICATIONS

Bachelor\'s degree in Statistics, Biostatistics, Mathematics, Computer Science or related field with minimum 7 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory agency.

Awareness 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.)

Awareness of regulatory requirements and relevant data standards (CDISC knowledge and experience are preferable)

Demonstrates strong verbal and written communication skills including ability to communicate remotely

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

Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

PHYSICAL/MENTAL REQUIREMENTS

Primarily an office-based position involving sitting in front of a computer for large periods of work time, making presentations, etc.

ORGANIZATIONAL RELATIONSHIPS

Reporting relationship to Associate Director, Group Lead, Data Management Reporting and Analytics, Process, Testing, Reporting & Analytics, CDS

  • Supports Study and Asset teams across Pfizer Research and Development/Oncology Research and Development/Discovery and EarlyDevelopment including Global Regulatory, Center of Excellence and Global Biometrics and Data Management
Financial Accountability

Align with Clinical Data Sciences (CDS)strategy to ensure responsible, efficient use of resources for Data Management Reporting and Analytics deliverables within budget and accountable for individual expenses.

Work Location Assignment: Flexible

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

Medical

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Pfizer

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Job Detail

  • Job Id
    JD3200115
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Chennai, Tamil Nadu, India
  • Education
    Not mentioned
  • Experience
    Year