Senior Statistical Programmer/Analyst Consultant (Need solid oncology background) Remote in US

Remote; San Francisco (CA); Remote; USD 120,000 - 180,000; Full time

Job summary

ClinChoice is seeking a Senior Statistical Programmer Consultant to join one of our client teams in a client-facing CRO role. The ideal candidate will independently lead statistical programming activities across oncology studies, collaborating with statisticians and cross-functional teams to deliver high-quality SDTM/ADaM datasets and TLFs.

Strong SAS expertise, CDISC standards, and experience with regulatory submissions are essential.

Qualifications

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, or Computer Science.
• Strong experience in clinical trial statistical programming.
• Significant experience working on oncology clinical trials.
• Basic knowledge of R programming.
• Experience supporting regulatory submissions.
• Strong proficiency in SAS programming.
• Strong knowledge of CDISC standards (SDTM/ADaM).
• Experience developing and validating TLFs for trials.
• Ability to independently manage programming deliverables and lead study activities.

Responsibilities

• Lead statistical programming activities for oncology trials from start-up to database lock and reporting.
• Develop, review, and maintain SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).
• Lead analyses and support complex efficacy and safety analyses.
• Collaborate with Biostatisticians to interpret SAPs and study requirements.
• Create and validate CDISC-compliant SDTM and ADaM datasets.
• Generate and validate TLFs for study reports and regulatory submissions.
• Perform independent programming validation and QC of outputs and datasets.
• Support submission-related activities and respond to data-related queries.
• Provide technical guidance and mentorship to programming staff.

Skills

SAS programming

CDISC standards

Oncology trials

Clinical trial programming

Regulatory submissions

R programming

Communication skills

Education

Bachelor's or Master's in Statistics/Biostatistics/Mathematics/Computer Science

Tools

Base SAS

ADaM/SDTM tooling knowledge

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

We are seeking an experienced Senior Statistical Programmer with strong expertise in clinical trial programming and a solid background in oncology. The successful candidate will be capable of independently leading statistical programming activities across clinical studies, partnering closely with statisticians, clinical teams, and other cross-functional stakeholders.

This role requires strong technical expertise in SAS programming, CDISC standards, and clinical trial reporting, along with the ability to take ownership of programming deliverables and provide guidance to junior team members.

Key Responsibilities

• Lead statistical programming activities for clinical studies within the oncology therapeutic area, from study start-up through database lock, analysis, and reporting.

• Develop, review, and maintain high-quality SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).

• Lead programming activities for interim and final analyses, including complex efficacy and safety analyses.

• Work closely with Biostatisticians to understand statistical analysis plans, programming specifications, and study requirements.

• Develop and review programming specifications and ensure consistency with study protocols, SAPs, and statistical methodology.

• Support the creation and validation of CDISC-compliant SDTM and ADaM datasets.

• Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables.

• Perform independent programming validation and quality control of statistical outputs and datasets.

• Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams.

• Identify potential programming issues and proactively communicate risks, timelines, and solutions to project stakeholders.

• Coordinate programming activities across studies and ensure deliverables are completed within agreed timelines and quality standards.

• Provide technical guidance and mentorship to Statistical Programmers and other programming team members.

• Participate in client/project meetings and effectively communicate technical information to both technical and non-technical stakeholders.

Required Qualifications

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.

• Strong experience in clinical trial statistical programming, preferably within a CRO, pharmaceutical, or biotechnology environment.

• Significant experience working on oncology clinical trials.

• Basic or working knowledge of R programming is preferred.

• Experience supporting regulatory submissions

• Strong proficiency in SAS programming, including Base SAS and relevant SAS procedures used for clinical trial reporting.

• Strong knowledge of CDISC standards, particularly SDTM and ADaM.

• Experience developing and validating TLFs for clinical trials.

• Experience working with complex clinical trial data and supporting statistical analyses.

• Ability to independently manage programming deliverables and lead study-level programming activities.

• Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports.

• Excellent communication, organizational, problem-solving, and collaboration skills.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.