Director Stats Program (Secondment - 6 months)
Director Stats Program (Secondment - 6 months)
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Salary Not Disclosed
1 Vacancy
Job Description
What You Will Achieve
This supervisory role will oversee and lead biomarker statistical analysis requests and resourcing activities supporting study and asset teams as well as cross-functional lines
Responsible for overseeing all BM specific request in the delivery of complex biomarker statistical programming activities
Ensures CDISC compliance data standards excellence in the programming of study data tabulation models for GF PF MI MB LB IS domains analysis ready datasets and TLFs
Ensures adherence to high quality programming standards
Excellent interpersonal skills and working in a matrixed environment with both pre-clinical and clinical biomarker stakeholders
Self-motivated to advance ones knowledge on evolving and complex scientific research and discoveries
External collaboration and participation with Industry Pharmacogenomics working group and CDISC GF standards subteam
Strong scientific training and understanding of the technologies behind biomarker data measurements in the research labs
Experience in understanding FDA expectations on biomarker/virology statistical analysis and bSAP/vSAP in order to meet the agencies requirements
Experienced in interpreting and decoding biomarker SAP/virology SAP for the programmers to execute the analysis
Review and oversee upstream study start up data collection forms (both CRF and non-CRF) of crucial biomarker data elements/metadata are properly designed and collected to support analysis needs
Manage and prioritize critical deliverables to ensure timelines are met
Active involvement with implementating overall biomarker reporting strategy cross-functionally
How You Will Achieve It
Accountable to manage programming resource evaluate and assign biomarker requests to programmers per complexity of the biomarker analysis timeline and programmers experience
Serve as a mentor/SME to programmers for better understanding of specific biomarker collected data for a particular project study or asset deliverable
Supervise completion of appropriate programming and QC documentation for all BM related deliverables
Supervise and oversee programming leads to ensure clear specifications are in place for programming deliverables and following appropriate Pfizer SOPs
Extensive knowledge and experience of other CDISC safety and efficacy standards and domains
Qualifications
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.
Must-Have
Bachelor with 8 years of pharma experience degree in Statistics Biological Sciences (molecular biology/bioinformatics preferred) or related fields
Intrinsic understanding of various type of biomarkers (genomics findings whole exon/transcriptome sequencing mutations infusions non-host organism infectivity proteomics immunohistochemistry)
In depth understanding and execution of relevant CDISC standards related to biomarkers and their control terminologies
Understand end to end biomarker data flow from data collection to regulatory submission requirement
Experience in preparing eSub package (CDISC compliance SDTMs ADaMs xDRGs ) and resolve/explain pinnacle 21 error/warning messages
At least 5 years relevant statistical programming experience in SAS or R programming as well as knowledge of clinical drug development and clinical study data
Strong written and oral communication skills and time management skills
Proven ability to manage deliverables under tight timelines and limited oversight
Experienced in working in multi-matrix environments interacting with cross-functional teams
Nice-to-Have
Master degree with 7 years of experience with degree in Statistics Biological Sciences (molecular biology/bioinformatics preferred) or related fields
Other Job Details
Last Date to Apply for Job:July 11 2025
Additional Location Information:United States - California - La Jolla United States - Connecticut - Remote United States - Massachusetts Cambridge
Eligible for Relocation Package NO
Secondment 6 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
PHYSICAL/MENTAL REQUIREMENTS
Office job involving use of computer.
Work Location Assignment:Hybrid
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 providers 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.
Required Experience:
Director
Employment Type
Full-Time
