Senior Statistical Programmer

Valtera Group Ltd; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Valtera Group Ltd. is seeking an experienced Lead Statistical Programmer for an initial 6-month contract in the United States. The role is hands-on, requiring independence, fast ramp-up, and a focus on regulated programming, CSR delivery and submission-ready data packages.

You will lead programming across multiple oncology studies, while staying hands-on with SAS and CDISC standards. Key responsibilities include owning timelines, validating SDTM/ADaM outputs, and coordinating with CROs and

Qualifications

• Extensive hands-on SAS programming in biotech/pharma settings.
• Strong SDTM/ADaM and TLF/TLG deliverables experience.
• Experience leading programming for clinical studies, especially in oncology.

Responsibilities

• Lead programming across 1–4 clinical studies.
• Remain hands-on in SAS and validate SDTM/ADaM outputs.
• Support CSR submission-ready data packages and regulatory deliverables.
• Review CRO datasets and outputs; manage validation and approvals.
• Collaborate with Biostatistics, Data Management and Clinical Operations.
• Own timelines and communicate risks early to protect milestones.

Skills

SAS programming

SDTM/ADaM

Oncology trials

CSR submission

Pinnacle 21

CDISC validation

Regulatory environment

Leadership/ownership

Timelines management

Tools

Pinnacle 21

Job description

Contract: Initial 6 months, potential extension

Hours: Full-time, approximately 40 hours per week

Start: ASAP

The Opportunity

We are partnering with a clinical-stage biotechnology company seeking an experienced Lead Statistical Programmer to provide immediate support across a portfolio of oncology clinical studies.

This is a hands-on contract position, not a purely oversight-focused role.

You will take ownership of programming activities across multiple studies, independently lead assigned studies, deliver critical year-end/CSR milestones, and provide technical oversight of CRO programming work.

The team needs someone who can get up to speed quickly, work independently and deliver within a regulated clinical environment with minimal hand-holding.

What You’ll Be Doing

• Lead statistical programming activities across 1-4 clinical studies.
• Remain hands-on in SAS, developing and validating SDTM, ADaM and TLF/TLG deliverables.
• Support study close-outs, CSR delivery and submission-ready data packages.
• Review and validate CRO-generated datasets, specifications and programming outputs.
• Work with Pinnacle 21 to identify and resolve validation findings.
• Support submission documentation including Define-XML and ADRG/SDRG.
• Work closely with Biostatistics, Data Management, Clinical Operations and other clinical stakeholders.
• Own programming timelines and proactively communicate risks, delays and quality issues before they impact milestones.
• Work consistently within established SOPs, specifications and validation processes.

Key Non-Negotiables

We are specifically looking for someone with:

• 6+ years’ statistical programming experience within biotech, pharma or a leading CRO.
• Strong, recent and genuinely hands-on SAS programming expertise.
• Experience independently leading statistical programming for clinical studies.
• Strong SDTM, ADaM and TLF/TLG experience.
• Meaningful oncology clinical-trial experience, including complex efficacy endpoints and/or tumour-response data.
• Previous CSR and regulatory-submission experience.
• Hands-on experience with Pinnacle 21 and CDISC validation.
• Strong understanding of GCP, SOPs, data integrity and regulated programming environments.
• The ability to work independently while communicating proactively with a remote, cross-functional team.

Particularly Relevant Experience

Strong candidates may also bring experience with:

• RECIST and tumour-response programming.
• Oncology endpoints including OS, PFS, ORR and DOR.
• Define-XML and reviewer guides.
• NDA/BLA/eCTD submission packages.
• Study close-out and CSR delivery.
• R programming alongside SAS.

What Good Looks Like

This role will suit someone who is technically strong but also takes genuine ownership.

You should be comfortable joining active studies, understanding what needs to be delivered quickly and taking responsibility for getting it done.

That means:

• following agreed specifications and SOPs;
• identifying problems before they become delivery risks;
• escalating issues proactively;
• communicating clearly with technical stakeholders;
• challenging unclear requirements constructively; and
• balancing speed, accuracy and regulatory quality.

If you are a senior statistical programmer who still enjoys being hands-on technically, has independently led oncology studies and can step into a fast-moving clinical environment with minimal ramp-up time, this could be an excellent contract opportunity.