Senior Statistical Programmer - Elan Solutions LLC

Title: Senior. Statistical Programmer (Full Time, Hybrid)

This role, within an oncology-focused client that specializes in creating targeted cancer therapies, is highly visible and has the potential to progress into a leadership position, depending on the exhibited abilities in time management, leadership, and organization. Responsibilities include meeting study deadlines, maintaining high-quality standards, and working collaboratively with internal teams, Statisticians, and other departments.

Depending on your level of experience, the job title may differ. As a Senior Statistical Programmer, your primary duties will involve:

• Offer statistical programming expertise to aid in the creation of tables, listings, and figures for designated projects.
• Expertise in CDISC, SDTM, ADaM for supporting various submission activities like IA, CSR, DSUR. Publications
• Manage all aspects of statistical programming, collaborating closely with statisticians to ensure the delivery of all statistical outputs
• Develop detailed specifications for individual studies and comprehensive summaries.
• Direct and supervise CRO tasks pertaining to statistical programming, including crafting and validating SDTM and ADaM datasets.
• Generate Safety tables, Efficacy tables and Lab Shift Tables as per the SAP and Mocks
• Examine statistical analysis plans, annotated CRFs, and integrated summaries, providing insightful feedback.
• Validating datasets and tables by double programming
• Good understanding of oncology specific domains a plus
• Guarantee meticulous planning, strict adherence to programming protocols, and the veracity of clinical trial data for both internal and external stakeholders.
• Engage in initiatives aimed at enhancing processes and actively participate in programming tasks for internal needs, and present in the internal Committees and Board of Directors meetings.

Required Skills, Experience, and Education:

• A masters or bachelors degree (or an equivalent qualification) in a relevant field is required.
• A minimum of 7-8 years of robust statistical programming experience with clinical trial data, specifically using SAS software, is essential.
• The ideal candidate excels in a team-oriented environment, is eager to adopt innovative methods and technologies, and contributes positively to team dynamics.
• A quick learner with a solid history of effective collaboration and teamwork.
• Outstanding communication skills, both written and verbal.
• Proven ability to multitask, prioritize tasks, foresee potential challenges, and achieve objectives within a multidisciplinary team setting.
• Prior experience in oncology and vendor management is highly desirable.

Must Have:

The ideal candidate will possess experience in spearheading or jointly leading studies in the capacity of a Statistical Programming Lead. Preference will be given to those with a background in oncology. The role requires a minimum of two days of on-site presence per week.

The expected salary range for this role is $124,000 to $157,000, influenced by various factors. The salary is a component of the organizations extensive total rewards scheme, encompassing competitive monetary remuneration, stock options, benefits, and opportunities for learning and development. The company is committed to equal employment opportunities and strictly forbids any form of discrimination on the basis of protected attributes.