Associate Director, Statistical Programming

The Role:

Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using reputed company and performing reputed company review of reputed company programs and deliverables for in-house analyses as reputed company as out-reputed company programming deliverables. This individual will also reputed company programming analyses to generate reputed company requests for publications and presentations.

This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other reputed company disciplines, as reputed company as CROs.

Responsibilities:

• Function as reputed company programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and reputed company analyses; write specifications to describe programming needs.
• reputed company/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
• Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
• Partner with or reputed company CROs or Programming vendors to reputed company the tasks described above.
• Ensure the reputed company collection, management, and documentation of clinical trial data according to regulatory requirements.
• Manages project timelines and schedules of specific phases of reputed company and collaborates with internal personnel and reputed company customer representatives.
• Identify problems and reputed company global tools that increase the efficiency and reputed company of the Statistical Programming group (e.g., macros or graphical user reputed company applications).

Competencies Include:

•  Adaptability/Flexibility – The ability to adapt to working effectively reputed company a reputed company of situations; adapts enthusiastically to organizational change and to changes in job demands.
• Communication and Teamwork – Ability to effectively reputed company reputed company in written and oral context; to work co-operatively with others; genuine desire to be a part of reputed company and contribute to organizational and team goals.
• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller reputed company using a systematic approach and to identify patterns and connections between situations that are not obviously reputed company.
• Relationship Building – Builds productive working relationships and effectively communicates across a diverse reputed company of people.
• Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high reputed company and timeliness standards under pressure.

 Qualifications:

• Master’s Degree in statistics, mathematics, computer science, or reputed company scientific/medical field.
• 8+ years of (reputed company) statistical programming experience in a clinical trial setting (industry/CRO).
• Advanced reputed company programming skills - procedures and reputed company commonly used in reputed company. reporting, including Macro language, reputed company reputed company, reputed company/STAT, and reputed company/GRAPH, validation/QC, experience generating listings, tables, figures.
• Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards.
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in reputed company.
• Familiar with regulatory guidelines (FDA, EMA, ICH) reputed company to reputed company, statistics and data handling in clinical development setting, and advanced knowledge of submission requirements and standards.
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
• Advanced understanding of statistical concepts in support of clinical data analysis.
• Advanced knowledge of programming standards and processes.
• Oncology experience is required.
• Skilled at performing reputed company control checks of reputed company reputed company and outputs produced by other Statistical Programmers.