Principal Statistical Programmer FSP

Cytel; Mumbai City; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Cytel in India is seeking a dedicated Principal Statistical Programmer embedded with a pharmaceutical client team to lead and deliver high-quality programming for clinical trials.

You will implement SDTM/ADaM, generate datasets, listings, and tables, and collaborate with CROs and regulatory teams while adhering to FDA/ICH guidelines and CDISC standards.

Qualifications

• Minimum bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and CDISC standards (SDTM, ADaM, Define.xml).
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently with strong communication and leadership skills.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewers guides, and define.xml files.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality programming results and maintain SAS/R programs for clinical programs.
• Oversee CROs' statistical programming deliverables across multiple studies.
• Assist in preparing clinical study reports, submissions, publications, and DSURs.
• Adhere to FDA regulations and guidelines for electronic submissions.
• Contribute to development of standards, CRFs, edit checks, and data validation plans.
• Collaborate with internal/external partners to meet timelines and goals.

Skills

SAS

CDISC

SDTM/ADaM

Define.xml

FDA/ICH

Leadership

Communication

R

Python

Git

Education

Bachelor's degree (CS/Math/Statistics)

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Sponsor

• Dedicated Principal Statistical Programmer

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit at 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 across 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.

We want our employees to succeed and enable this success through consistent training, development, and support. To be successful in this position you will have: a minimum bachelors degree in computer science, data science, mathematics, or statistics (major preferred), plus 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team 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 are essential. You must bring extensive applied experience with CDISC standards (SDTM, ADa. M, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations. Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities is required. You must be able to work independently and possess outstanding communication skills (written and verbal) along with strong leadership skills.

Preferred qualifications include prior work experience with pharmacokinetic data and the neuroscience field, as well as proficiency in languages or tools other than SAS such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git.

Your responsibilities will include:

• Generating SDTM, ADa. M specifications, datasets, reviewers guides, and define.xml files for multiple studies
• Developing SAS programs that generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
• Delivering high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs needs
• Participating in overseeing CROs statistical programming deliverables for multiple clinical studies to ensure high quality and adherence to pre-specified timelines
• Supporting the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understanding and following FDA regulations that affect the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions
• Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participating in the development of CRFs, edit check specifications, and data validation plans
• Providing review and/or authoring data transfer specifications for external vendor data
• Collaborating with internal and external functions (e.g., CROs, software vendors, clinical development partners) to ensure project timelines and goals are met
• Providing review and/or authoring SOPs and Work Instructions related to statistical programming practices