Senior Statistical Programmer

Senior Statistical Programmer

Location : Remote

Duration : 12-month contract with potential to renew long-term

Interview : Virtual round

Not interested in candidates with CRO experience. Again, looking for Lead level programmers with recent experience supporting small pharma companies (very different environment than a CRO). Also, not interested in people that have only worked for large pharma companies.

Note :

Should have working experience in a pharma domain company

Candidate must be in PST or represent them

Statistical Programming & Deliverables

Develop and review programming components for CRFs, SAPs, analysis dataset specifications, and TFL shells.

Program and validate analysis datasets and TFLs to support NDAs, sNDAs, integrated summaries, and post-submission requests.

Convert, clean, verify, and integrate multiple incoming data sources for analysis dataset creation.

Generate rapid, ad hoc analyses in response to clinical or statistical inquiries.

Ensure all programming deliverables meet quality, regulatory, and timeline expectations.

Standards, Tools & Compliance

Apply and ensure adherence to industry standards, including CDISC (SDTM and ADaM) and Define XML.

Contribute to the development, maintenance, and validation of departmental programming tools and macros.

Maintain documentation to audit-ready standards in accordance with internal SOPs and regulatory guidelines.

Collaboration & Cross-Functional Support

Partner with Biometrics, Clinical Operations, Regulatory Affairs, and Clinical Development.

Provide input into clinical database design to optimise data capture and ensure data quality.

Support a collaborative, team-focused culture.