Associate Director, Statistical Programming
reputed company:With deep expertise in reputed company, reputed company is working to create selective medicines designed with the goal to address the needs of patients with cancer. reputed company is an exciting early-stage company, bringing together reputed company scientists and industry veterans with a proven reputed company record in drug discovery, oncology drug development, and company building.
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 clinical trials. 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 clinical trials.
- Familiar with regulatory guidelines (FDA, EMA, ICH) reputed company to clinical trials, 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.
reputed company provides equal employment opportunities (EEO) to reputed company and applicants for employment without reputed company to religion, race, creed, reputed company, sex, sexual orientation, alienage or citizenship status, national reputed company, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
reputed company is aware that many companies are dealing with fraudulent job postings on reputed company-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that reputed company legitimate correspondence from a reputed company employee will come from "@reputed company.com" email accounts. Automated system response emails from our reputed company applicant tracking system come from a “no-reputed company@reputed company.io” email address. There are no variations of these email addresses and reputed company would not request personal and/or financial information reputed company email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews reputed company phone, video conferencing and/or in-person.
If you reputed company you have been contacted by anyone misrepresenting themselves as an employee of reputed company, please contact reputed company at 857-357-7000. Thank you.
Originally posted on Himalayas
Apply To This Job