Description:

• A Master's or Ph.D. degree in Biostatistics, Statistics, or a related field.

• A minimum of 3 years of experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.

• Proficiency in statistical software such as SAS or R.

• Strong knowledge of CDISC SDTM and ADaM

• Working knowledge of clinical trial design, statistical methodologies, and regulatory requirements, including FDA and ICH guidelines.

Skills:

Analysis, Statistical analysis, Drug development, Data, Clinical data, Biometrics, Clinical studies, Pharmaceutical, Sas, Oncology

Additional Skills & Qualifications:

POSITION SUMMARY:

The incumbent is responsible for providing statistical support and guidance for our ongoing and upcoming projects. Your expertise will contribute to the analysis and interpretation of clinical studies. As a vital part of our team, this role will partner with other stakeholders in studies including statistical programmers and data managers.

KEY ROLE AND RESPONSIBILITIES:

• Develop and review statistical analysis plans, including the selection of appropriate methodologies and sample size calculations, in collaboration with cross-functional teams.

• Conduct statistical analyses of clinical trial data, ensuring accuracy and adherence to industry standards.

• Generate and interpret statistical summaries, and visualizations for internal and external stakeholders.

• Participate in the development and review of study protocols, case report forms, and data management plans to ensure the collection of high-quality data for analysis.

• Review and QC of statistical deliverables (tables, listings, figures, etc.)

• Assist in the preparation of regulatory submissions and scientific publications, including providing statistical analyses and QC.

• Stay updated on relevant regulatory guidelines and industry trends to ensure compliance and the implementation of best practices.

PREFERRED Qualification:

• A Master's or Ph.D. degree in Biostatistics, Statistics, or a related field.

• A minimum of 3 years of experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.

• Proficiency in statistical software such as SAS or R.

• Strong knowledge of CDISC SDTM and ADaM

• Working knowledge of clinical trial design, statistical methodologies, and regulatory requirements, including FDA and ICH guidelines.

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and present statistical concepts to non-technical audiences.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.