Senior Statistical Programmer

Valos Srl; Kolkata District; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Flexible working arrangements

Professional development opportunities

International team collaboration

Job summary

A global contract research organization is seeking a Senior Statistical Programmer in Kolkata, India. This mid-senior level position requires at least 5 years of experience in statistical programming, particularly with SAS and R. The role involves responsibilities such as creating TFLs for clinical studies and developing Statistical Analysis Plans. The company provides flexible working arrangements and opportunities for professional growth, making it an excellent choice for those aiming to contribute to impactful research.

Qualifications

• Solid understanding of clinical trials and TFL production.
• Able to work with interventional and observational data.
• Experience with SDTM and ADaM specifications.

Responsibilities

• Create ADAM and TFLs for clinical studies.
• Develop Statistical Analysis Plans and study reports.
• Collaborate with cross-functional teams in clinical operations.

Skills

Strong SAS Base and Macro

Working R for data manipulation

Statistical knowledge for programmers

Validation mindset

Ability to maintain shared code

Clear, concise English communication

Tools

SAS

R

Job description

VALOS is an international, specialized CRO headquartered in Genoa, Italy, www.valos.it, recognized for its excellence in Biostatistics and Data Management. We partner with leading pharmaceutical and biotech companies worldwide, delivering high-quality statistical solutions that drive clinical research forward.

About the Role

We are looking for a talented Senior Statistical Programmer with at least 5 years of experience to join our growing Biostatistics Department in India.

Responsibilities

• Create ADAM and TFLs for clinical studies
• Apply advanced statistical methodologies to clinical trials and RWE studies
• Contribute to the development of Statistical Analysis Plans (SAPs) and study reports
• Collaborate closely with cross-functional teams (data management, Statisticians, medical writing, clinical operations)

Qualifications

• Solid understanding of clinical trials across 1-4 phases, different endpoints, analysis populations, and why TFLs are produced.
• Able to work with interventional and RWD or observational data.
• Read and interpret Protocol and SAP. Translate methods and estimands into programming requirements and traceability rules. Provide programming feedback to Statisticians and align on shells.
• Build SDTM from raw sources with end-to-end traceability to CRF and EDC exports.
• Perform precise SDTM CRF annotation aligned to CDISC SDTM IG and trial design domains.
• Apply controlled terminology and clinical dictionaries (Meddra, WHODrug, etc) in SDTM mapping
• Prepare SDRG and SDTM Define.xml. Run and resolve SDTM Pinnacle 21 findings.
• Create ADaM specifications from SAP and shells with clear derivation rules and SDTM-to-ADaM traceability.
• Program ADaM across ADSL, BDS, OCCDS, and time-to-event. Produce ADaM Define.xml and ADRG. Close ADaM Pinnacle 21 findings.
• Understand and build TFL mock shells consistent with SAP and ADaM structure. Program and validate TFLs in SAS and R.
• Execute QC: independent review, double programming where applicable, internal checklists, full documentation discipline, and issue tracking to closure.
• Assemble submission-ready packages: datasets, programs, XPT, Define, ADRG, SDRG, meeting expectations of EMA, FDA, PMDA and other regulatory authorities.
• Lead or support pooled analyses and exploratory requests. Coordinate ISS and ISE datasets and outputs when required.

Required Skills

• Statistical knowledge appropriate for programmers.
• Strong SAS Base and Macro with ability to modify and maintain shared code and macros.
• Working R for data manipulation, automation, and reproducible reporting.
• Proven validation mindset and familiarity with GCP, ICH, and CDISC compliance expectations.
• Clear, concise English. Effective collaboration with Statisticians, Data Managers, Medical Writers, and Sponsor teams across time zones.
• Accountable, detail-focused, and organized. Able to plan timelines, communicate risks early, and deliver to quality and schedule in a multi-study environment.

Preferred Skills

• Experience as Statistical Programmer within a CRO or pharmaceutical company is required.

Pay range and compensation package

Why Join VALOS?

• Be part of a specialized and collaborative international team with offices in Italy, USA and East Europe
• Work on a diverse portfolio of clinical studies across therapeutic areas
• Benefit from flexible working arrangements and continuous professional development
• Contribute to high-impact research improving patient outcomes worldwide

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Project Management

Industries

Pharmaceutical Manufacturing and Biotechnology Research

Kolkata, West Bengal, India