Senior Principal Statistical Programmer Consultant(Oncology-Medical Affairs, Clinical Trials) REMOTE
Senior Principal Statistical Programmer Consultant(Oncology-Medical Affairs, Clinical Trials) REMOTE
at ClinChoice (View all jobs)United States
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 Principal Programmer Consultant to join one of our clients in their Medical Affairs Team.
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.
Job Summary:
We are seeking a highly experienced Senior Principal Statistical Programmer with a strong background in Medical Affairs and Oncology/Hematology Therapeutic Area. This role will involve leading statistical programming activities for clinical trials and post-marketing studies, ensuring high-quality deliverables to support regulatory submissions, publications, and medical communications.The ideal candidate will have a deep understanding of clinical trial data analysis and the ability to collaborate with cross-functional teams, including statisticians, data managers, and regulatory professionals.
Key Responsibilities:
- Lead statistical programming activities for clinical trials, post-marketing, and medical affairs studies, particularly in oncology/hematology.
- Develop Tables, Figures, Listings (TFLs) deliverables from existing SAS programs for Clinical Study Report (CSR) if similar TFLs exist and from scratch for new outputs.
- Responsible for supporting the Programming deliveries of a clinical study or project.
- Capacity for independent programming and review of reports and outputs.
- Customize outputs and graphics according to delivery specifications of target audience on the direction of biostatisticians.
- Collaborate with the biostatistics, clinical, and data management teams to ensure alignment of programming activities with study protocols and statistical analysis plans.
- Lead the programming support for Medical Affairs initiatives, including real-world evidence (RWE), post-marketing safety, and HEOR studies.
- Review and provide feedback on protocols, statistical analysis plans (SAPs), and case report forms (CRFs).
Required Qualifications:
- Bachelor’s or Master’s degree in statistics, computer science, mathematics, or a related field.
- Minimum of 9 years of experience in statistical programming in the pharmaceutical, biotechnology, or CRO industry.
- Working knowledge of SDTM and ADaM data models to develop new endpoints and/or new populations.
- Knowledge of statistical methodologies, such MMRM, survival analysis, ANOVA/ANCOVA, rates and proportions, confidence intervals, and non-parametric analysis.
- Knowledge of registry databases, RWE, HEOR, claims data, HTA regulatory requirements is a plus.
- Extensive Oncology/Hematology Therapeutic Area experience, with a strong understanding of clinical trials in oncology/hematology.
- Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional teams.
- Ability to work in a fast-paced, deadline-driven environment, managing multiple priorities.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
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.
#LI-TT1 #LI-Remote #Senior #Contract