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ClinChoice

Senior Statistical Programmer /Analyst Consultant (3 days Hybrid at Malvern PA)

ClinChoice · United States

  • Hybrid
  • Contract
  • $100,000 / year
  • United States
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Job highlights

  • Program and validate clinical trial data for submissions.
  • Work with SAS and R programming languages.
  • Contribute to study design and documentation.
  • Manage internal contractors and external vendors.
  • Ensure high-quality, on-time deliverables.

About the role

About the Role

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 a 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

The contract Senior Statistical Programmer is a member of the Biometrics Department within the Research and Development (R&D) organization who supports Statistical programming work in accordance with corporate standard operating procedures (SOPs), GCP, 21 CFR and ICH guidance.

Responsibilities

Programming for clinical trials:
  • Program and validate derived datasets, tables, figures, listings. Process data from external sources.
  • Perform ad hoc exploratory analyses for publications and programming support for other functions of Research and Development or other organizations.
  • Oversee programming work/deliverables from CROs.
  • Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.
Electronic submissions:
  • Program and validate CDISC compliant deliveries for electronic submissions.
  • Support in the creation of supporting documentation for submissions.
Project Management:
  • Ensure programming deliverables are on time and of high quality.
  • Help manage internal contractors and external vendors.
Standards and Guidelines:
  • Participate in the development of departmental working instructions and guidelines.
  • Help in the creation of enhanced functions/macros and utilities.

Qualifications & Experience

  • Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
  • BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
  • Working knowledge of SAS and its various components.
  • Knowledge of R programming in clinical trials.
  • Familiarity with the drug development process.
  • Strong SAS and SAS Macro language skills.
  • R programming skills in clinical trials.
  • Strong knowledge of industry standards.
  • Ability to work on data integrations (ISS and ISE).
  • Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.

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 a 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.

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.

Key skills/competency

  • Senior Statistical Programmer
  • Clinical Trials Programming
  • SAS Programming
  • R Programming
  • CDISC Standards
  • Data Integration
  • Pharmaceutical Industry
  • Statistical Analysis Plan
  • Electronic Submissions
  • Project Management

Skills & topics

  • Senior Statistical Programmer
  • Statistical Programmer
  • SAS
  • R
  • Clinical Trials
  • Pharmaceutical
  • CRO
  • Biometrics
  • Data Analysis
  • CDISC

How to get hired

  • Tailor your resume: Highlight SAS, R programming, and clinical trial experience.
  • Craft a compelling cover letter: Emphasize your client-facing skills and project management abilities.
  • Prepare for phone screening: Be ready to discuss your statistical programming background and qualifications.
  • Showcase technical expertise: Demonstrate your understanding of CDISC standards and drug development.
  • Research ClinChoice: Understand their CRO services and company culture.

Technical preparation

Master SAS and SAS Macro language.,Practice R programming for clinical trials.,Understand CDISC SDTM/ADaM standards.,Review drug development process.

Behavioral questions

Describe a complex programming challenge.,How do you manage client expectations?,Explain your approach to data quality.,How do you collaborate with cross-functional teams?

Frequently asked questions

What is the work arrangement for the Senior Statistical Programmer Consultant role at ClinChoice?
The Senior Statistical Programmer Consultant role at ClinChoice operates on a hybrid model, requiring 3 days per week onsite in Malvern, PA, with the flexibility of remote work for the remaining days.
What are the primary responsibilities of a Senior Statistical Programmer Consultant at ClinChoice?
Primary responsibilities include programming and validating derived datasets, tables, figures, and listings for clinical trials, supporting electronic submissions with CDISC compliant deliverables, and contributing to study documentation and project management.
What qualifications are required for the Senior Statistical Programmer Consultant position?
A Bachelor's or Master's degree in a related field is required, along with 3-5+ years of statistical programming experience in the pharmaceutical industry using SAS and R, and familiarity with the drug development process and CDISC standards.
How does ClinChoice support professional development for its employees?
ClinChoice emphasizes professional development through continuous training, aiming to keep resources qualified in competence and expertise, and providing tools to manage processes effectively, which is reflected in their below-industry-average turnover rates.
What is the application process for this Senior Statistical Programmer Consultant role?
After submitting your CV, you will receive an acknowledgement. If you meet the requirements, you will be invited for a phone interview as the first step. Due to application volume, not all candidates will receive individual feedback.
Can I work remotely full-time for this Senior Statistical Programmer Consultant position?
No, this Senior Statistical Programmer Consultant position is a hybrid role, requiring 3 days of onsite work per week in Malvern, PA.
What programming languages are essential for the Senior Statistical Programmer Consultant role?
Proficiency in SAS (including SAS Macro language) and R programming, specifically within the context of clinical trials, is essential for this role.
Does ClinChoice value diversity and inclusivity in its hiring?
Yes, ClinChoice is an equal opportunity employer committed to diversity and inclusivity, celebrating employees from various backgrounds and recognizing this as a strength.