Manager - Specialized Data Programming, Statistical Programming Lead

Expiring today

Employer
Pfizer
Location
United Kingdom
Salary
Competitive
Posted
Sep 14, 2021
Closes
Sep 17, 2021
Ref
564002
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Full Time
  • A highly productive, independent hands on statistical programming point of contact ensuring excellence in the delivery of specialized PK/PD statistical programming deliverables such as: PopPK, PKPD and PKECG, PKBP, etc. type datafiles, Regulatory Submission Component Compilation supporting regulatory submissions or regulatory information requests, or other statistical programming deliverables to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes
  • Ensures adherence to high quality programming standards in the production of clinical reports


Responsibilities:
  • Will deliver through combination of oversight of vendors/offshore support as well as through hands on programming
  • Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables for their study(ies)
  • Accountable for the quality and timely delivery of datasets and displays required for any programming deliverables they may contribute to. Ensures appropriate documentation across the lifespan of the study for all programming deliverables and verifies proper Trial Master File filings when appropriate.
  • Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data
  • Works with statisticians, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place
  • Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to their project, may aid in development of standards necessary for their study
  • Will contribute to department level initiatives
  • Proactive at communicating potential issues to upper management
  • Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations


Qualifications:
  • Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
  • At least 5 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
  • Statistical Programming and SAS hands-on experience
  • Experience generating NONMEM Datafiles including: PopPK, PKPD, PKECG and PKBP
  • Experience with compilation of PK/PD Regulatory Submission Components and Regulatory Information Request responses.
  • Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.
  • Good understanding of ICH and Regulatory Guidelines
  • Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.
  • Thorough understanding of clinical data and relevant data standards
  • Extensive knowledge of routine statistical methodology and its application to programming
  • Knowledge of vendor processes
  • Demonstrated experience in developing successful partnerships within study teams
  • Strong written and oral communication skills, and project management skills
  • Ability to present technical information to a non-technical audience
  • Proven ability to operate independently.
  • Some exposure working across international boundaries and cultures.
  • Ability to manage customer expectations.
  • Ability to manage work of others in a remote and/or global setting
  • CDISC experience highly desirable.
  • Experience with PK/PD, Biomarker, Pharmacogenomics or Real World Data desirable
  • R programming experience desirable


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.

#LI-PFE

#LI-REMOTE

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.

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