AmbitionBox
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
All Filters
9 Cytel Statistical Software & Services Jobs
Statistical Programmer II
3-8 years
Remote
1 vacancy
Statistical Programmer II
Cytel Statistical Software & Services
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Minimum Education : BSc or equivalent with research experience (preferably in Statistics, Computer Science, or Mathematics).
- Minimum Work Experience : 3 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of SAS BASE, STAT, MACRO, SQL, Graph, of CDISC guidelines, ICH Statistical and Clinical Report Guidelines. Relevant experience with at least one Therapeutic Area and exposure to the production/qc of SDTM / ADaM / ADaM s like Datasets, Tables, Listings and Figures.
- Good problem-solving skills.
- Good organizational skills.
- Detail-oriented with analytical mind-set.
- Fluent in English with good verbal and written communication skills.
- Good interpersonal skills with the ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Evolving knowledge of the pharmaceutical industry including understanding of clinical drug development process, regulatory requirements, interdependencies with other functions.
- Good ability in SAS programming
- Under light supervision, contribute to statistical programming activities: Program and/or QC statistical deliverables (Datasets, Tables, Listings and Figures) for statistical analysis.
- Occasionally develop program specifications and design documents under supervision of Senior Statistical programmer.
- Contribute to portions of a project under the guidance of senior statistical programming staff members, including client facing activities, ensuring high quality, respecting project timelines and adherence to the budget. These may include individual parts of a study or individual studies in a multi-study project.
- May mentor junior statistical programming staff members on SAS techniques and clinical trial data with respect to industry standards or other regulatory requirements.
- Attend relevant project meetings and work closely with other internal and external leads.
- Identify risks to project deliverables and timelines and notify the appropriate personnel.
- Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance: clinical study reporting, e.g. ICH E3, electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11, electronic submission of clinical data to agencies.
- Understand and follow all relevant standard operating procedures (SOPs).
- Understand and adhere to project specific clinical protocol(s): the clinical design, randomization schedule, per protocol analysis, statistical analysis, primary and secondary endpoints etc.,
- Understand and adhere to clinical Statistical Analysis Plan (SAP): describing how the clinical trial data will be analyzed (defines the study population, presents data windowing or other special data handling rules and often includes draft output shells that show precisely what tables, listings and graphs will be provided in the reporting).
- Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. Maintain up-to-date knowledge of programming software (e.g. SAS, R, Python) as well as industry requirements (e.g. CDISC, eCTD,...), attend functional meetings and trainings.
Employment Type: Full Time, Permanent
Read full job descriptionCytel Statistical Software & Services Interview Questions & Tips
Prepare for Cytel Statistical Software & Services roles with real interview advice
What people at Cytel Statistical Software & Services are saying
What Cytel Statistical Software & Services employees are saying about work life
Cytel Statistical Software & Services Benefits
View more benefits
Compare Cytel Statistical Software & Services with
SAS
IQVIA
Pharm Olam
Parexel International
ICON Plc
Syngene International
Aragen Life Sciences
SAI Life Sciences
Qinecsa Solutions
Fortrea Development India Private Limited
Syneos Health
Lambda Therapeutic Research
Reliance Life Sciences
Aizant Drug Research Solutions
Veeda Clinical Research
Rubicon Research
Cliantha Research
Ephicacy Lifescience Analytics
Accutest Research Laboratories
Navitas Life Sciences
Senior Statistical Programmer FSP
8-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
Principal Statistical Programmer FSP
7-9 Yrs
Kolkata, Mumbai, New Delhi +4 more
Senior Statistical Programmer FSP
8-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
Senior Statistical Programmer FSP
8-10 Yrs
Kolkata, Mumbai, New Delhi +4 more
Principal Statistical Programmer FSP
2-5 Yrs
Kolkata, Mumbai, New Delhi +4 more
