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Principal Statistical Programmer FSP
2-5 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Principal Statistical Programmer FSP
Cytel Statistical Software & Services
posted 1mon ago
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Flexible timing
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Job Description
This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- At a minimum bachelor s degree in computer science, data science, mathematics, or statistics major preferred
- 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
- Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
- Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
- Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
- Must be able to work independently
- Outstanding communication skills (written and verbal) and strong leadership skills
Preferred Qualifications (nice to have)
- Prior work experience with pharmacokinetic data and the neuroscience field,
- proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
SLP required for EOS reporting of a study 6 months earlier than planned. SAP/OPS writing required in Q4 2024/Q1 2025, Dry Run in 2025, LSLV in Oct2025. Immunology Benlysta SLE indication study. Prior experience in Pediatric studies, prior knowledge of PK, Laboratory Assessments such as B-cells, Immunogenicity, Anti-ds DNA C3/C4, IgA, IgG, IgM, Disease Activity Scales such as SELENA SLEDAI,SLE Flare Index, BILAG, Physician GA, Parent GA, Pediatric SLICC/ACR Damage Index, PedsQL and PedsQL Multidimensional Fatigue would be preferred but not required.
As a Principal Statistical Programmer, your responsibilities will include:
- Generate SDTM, ADaM specifications, datasets, reviewer s guide and define.xml files for multiple studies
- Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
- Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs
- Participate in overseeing CRO s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
- Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
- Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
- Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Participate in the development of CRFs, edit check specifications, and data validation plans
- Provide review and/or author data transfer specifications for external vendor data
- Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Cytel Statistical Software & Services Benefits
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