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Statistical Programming Lead (Standards) – Senior Manager

Employer
Pfizer
Location
Working from Home
Start date
May 16, 2022

View more

Discipline
Information Technology, Bioinformatics
Required Education
Bachelors Degree
Position Type
Full time

  • Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications needed to develop standard CDISC compliant software

  • Hands on experience developing CDISC ADaM analysis ready datasets and supporting tables, listings, and figures

  • Ensures adherence to Pinnacle 21 CDISC validation checks

  • Working understanding of software development lifecycle (SDLC) practices

  • Accountable for the management and delivery of assigned work

  • Provide oversight and guidance to Pfizer standards programming team and contract resources

  • In addition to management of the deliverables, the senior lead will also provide consultation to the asset/submission teams with respect to planning of programmed asset deliverables as well as standards strategy

  • Ensures adherence to high quality programming standards documentation

Role Responsibilities:

  • May have people management responsibilities

  • Will be a mentor to junior colleagues

  • Excellent communication skill to ensure appropriate collaboration with statisticians, data managers, statistical programmers, clinical pharmacology leads, research data scientists and programming leads to ensure clear specifications for their programmed deliverables are in place

  • Provide solutions to complex programming issues using problem solving skills and previous experience

  • Will contribute to and may lead department level initiatives. May also contribute to broader initiatives outside of the department

  • Represents Programming Standards within Global and TA Standards Boards

  • Represent Pfizer within industry forums (i.e., PhUSE, CDISC, Transcelerate, …)

Qualifications:

  • Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field

  • At least 5 years relevant statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency

  • Advanced statistical programming expertise using SAS (i.e., ODS, Base SAS, Macro Language, Statistics and Graphics)

  • Knowledge of CDISC is required

  • Cross Therapeutic Area experience highly desirable (Primary Areas of Interest: Oncology, Vaccines, I&I)

  • Knowledge of R and/or Python are highly desirable

  • Clinical trials data flow expertise from data collection through reporting

  • Adept at solving problems

  • Experience working with a global programming team is highly desirable

  • Demonstrated experience managing complex projects

  • Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills

  • Proven ability to operate independently in ambiguous situations

  • Proven ability to present technical information to a non-technical audience

#LI-PFE

#LI-Remote

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Medical

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