Provides leadership for the successful implementation of SDTM (Study Data Tabulation Model) data deliverables required for analysis, reporting, and regulatory submission
Advises to ensure study data deliverables are compliant with regulatory agency requirements and expectations
Accountable for a team of CDISC (Clinical Data interchange Standards Consortium) data standards experts
Sets the strategic and operating direction for the SDSQM SC team
Collaborates effectively with stakeholders at all levels in Biostatistics, Clinical Research, Data Management, Regulatory Affairs, and IT
Leads a team of submission consultants with varying levels of expertise
Has accountability and oversight for esubmission deliverables, and strategic and department responsibilities
Stays current with regulatory guidance and submission standards and is a recognized leader providing specific clinical development and analysis & reporting deliverables domain expertise to stakeholders and staff at all levels
Performs managerial and administrative duties including hiring, retention & engagement, coaching, mentoring, and people development
Applies domain and management expertise to set and achieve operational and strategic objectives within a group, manages broad initiatives, and leads and actively contributes to departmental objectives
Plays a role in developing and accomplishing priorities and objectives to align with the division scorecard
Promotes good stewardship of company resources

Requirements

Bachelors or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering
BS plus a minimum of 12 years or MS with 10+ years working in an analysis and reporting environment
2 years statistical programing experience in a clinical trial environment
7+ years of project management experience in the submission consultation, development and execution of statistical analysis and reporting deliverables
Expertise managing and forecasting team’s resources at the project and therapeutic area level
Broad knowledge and demonstrated experience in developing analysis and reporting statistical programming deliverables using global and TA standards and according to quality, compliance and timeliness requirements
Expertise in clinical trial programming, systems and databases including advanced knowledge of regulatory and CDISC data standards
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of submission deliverables
A deep understanding of both Late Stage Development and Early Stage Development business needs and regulatory requirements
Knowledge of regulatory agency requirements pertaining to statistical computing and programming issues
Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders; ability to engage key stakeholders
Demonstrated success in the assurance of deliverable quality and process compliance.
Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Experience leading the activities of a programming team that includes functional sourcing partners, domestic contractors, and global resources; ability and interest to work across cultures and geographies

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

statistical programmingclinical trial programmingdata analysisreporting deliverablesproject managementresource forecastingCDISC standardsregulatory submissionSOPsSDLC

Soft Skills

leadershipcommunicationnegotiationteamworkcollaborationchange managementstakeholder engagementcoachingmentoringpeople development