Statistical Programmer Ii

India (Remote)
- We are experiencing exponential growth on a global scale and hiring a Statistical Programmer II to join our PBS division. You will exercise your strong communication and leadership skills to support or lead one or more clinical trials, across various therapeutic areas. You will report to the Associate Director, Statistical Programming.RESPONSIBILITIES
- Conduct statistical programming activities for the reporting of clinical study data. Will have exposure to a variety of different sponsors, products and therapeutic areas. May work as lead programmer for portions of a project and mentor less experienced statistical programming staff.- 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.

QUALIFICATIONS
- 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.

**Skills**:

- 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

JOB INFO
- Job Identification
372
Job Category
Statistical Programming - PBS
Posting Date
02/04/2025, 05:36 AM
Locations
Remote, Pune, Maharashtra, 411038, IN

(Remote)
Job Schedule
Full time
- Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law._