Senior Principal Statistical Programmer Consultant (Oncology-Medical Affairs, Clinical Trials)

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 4000 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.

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