Manager, Statistical Programming
Gilead Sciences
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $133,195 - $172,370 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Exhibit strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers
- Attend SMT Meetings, providing functional input on programming related activities and potential risks
- Review and approve statistical programming requirements (e.g. ADaM Mapping Specifications)
- Communicate SMT decisions, discussions, and action items to statistical programmers
- Review and approve key study documents
- Help statistical programmers understand critical study documents
- Review statistical programming timelines and negotiate with study team if needed
- Participate in internal and external audits and identify areas of opportunity to refine and simplify procedural steps
- Analyze vendor performance through assessment of Key Performance and Quality Indicators (e.g. KPI, KQI), metrics, and results
- Participate as needed in vendor governance discussions to address any performance related risks and/or concerns
- Ensure adequate statistical programming resourcing for study milestones
- Assign tasks to statistical programmers based on experience and ability
- Closely monitor and track study statistical programming activities within task management system
- Maintain regular communications on study statistical programming milestone activities with appropriate study team members and stakeholders
- Influence and support data and submission standards, templates, etc.
- Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards
- Ensure programming activities are executed in correct order
- Ensure validation documentation, folder locking, and TMF requirements are observed
- Surface the need for new or updated standards to improve efficiency and uniformity across TA or Indication level objects
- Provide prioritization decisions and coaching to fellow onboarding staff as needed to advance their knowledge on Gilead processes and statistical programs & methods
- Ensure the programming team identifies data issues and enters accordingly into the Data Issue Log
- In addition, ensure all issues and observations noted on the issue log have been resolved prior to final production release
- Hold analysis team meetings with Biostatisticians
- Serve as the point-of-contact with vendors, and liaise with other functions
- Request the locking and archiving of study folders
Requirements
- BS degree in Biostatistics/Computer Science or equivalent with 6+ years of experience OR MS degree in Biostatistics/Computer Science or equivalent with 4+ years of experience OR PhD degree in Biostatistics/Computer Science or equivalent with 0+ years of experience
- Experiences leading late phase HIV studies in Virology TA
- Mature statistical knowledge and expertise in the development of ADaM and TFLs and dependent tasks/activities
- Proven track record in delivering high quality statistical programming datasets and outputs
- Ability to collaborate and work effectively with global team members and build strong relationships
- Expertise working in global teams, across various time-zones to achieve clinical trial milestones
- Remains current and has deep knowledge of GCP, ICH guidelines, and regulatory requirements, specifically as it relates to quality oversight, quality assurance, and risk management
- Ability to problem-solve using data-driven approaches to help determine the best path forward
- Excellent customer-focus with proven track-record in building relationships through superlative communication and writing skills
- Superior skills in coaching and mentoring staff of varying skillsets and respectful of cultural differences especially communication styles
- Results-oriented and able to work closely with others through great collaboration to resolve challenges, bottlenecks, or risks
- Ability to motivate large diverse teams to achieve a common set of goals
- Strong experience in data analysis and demonstrated critical thinking skills
- Deep knowledge in HIV study designs and analysis requirements
- Able to lead and mentor effective cross functional teams and keep programming team promptly informed of all study activities.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical programmingADaMTFLsdata analysisGCPICH guidelinesregulatory requirementsquality assurancerisk managementKPI
Soft skills
collaborationcommunicationcoachingmentoringproblem-solvingcustomer-focusresults-orientedrelationship buildingcritical thinkingmotivation