Senior Biostatistician

Clario; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Biostatistician to join their expanding team. This role involves creating and validating statistical outputs, developing SAS and R programs, and providing statistical support for clinical trials. The ideal candidate will possess a strong educational background in Statistics or Mathematics, along with significant experience in clinical trials. Join a forward-thinking company that values innovation and is committed to transforming lives through technology in clinical research. If you are passionate about statistics and eager to make a difference, this opportunity is perfect for you.

Benefits

Competitive compensation

Shift allowances

Attractive benefits

Engaging employee programs

Technology for hybrid working

Great onsite facilities

Qualifications

• PhD in Statistics, Mathematics or equivalent, or Master's with 4+ years experience.
• Strong programming skills in SAS and R, with clinical trials experience.

Responsibilities

• Develop and maintain SAS and R programs for statistical analysis.
• Create and validate statistical outputs for cardiac safety analysis.

Skills

SAS programming

R programming

ANOVA

t-test

regression analysis

linear mixed-effects modeling

communication skills

analytical skills

organizational skills

clinical trials experience

Education

PhD in Statistics or Mathematics

Master's degree in Statistics or Mathematics

Bachelor's degree in Statistics or Mathematics

Tools

Windows

Microsoft Office

Job description

Are you looking for a meaningful and fulfilling career in statistics? Our Biostatistical team in India is expanding, and with ambitious goals and a clear vision for the future, now is the time to join Clario as a Senior Biostatistician.

What we offer

• Competitive compensation + shift allowances

• Attractive benefits (security, flexibility, support and well-being)

• Engaging employee programs

• Technology for hybrid working and great onsite facilities

What you'll be doing

• Create, test and maintain SAS codes used to create and/or validate statistical outputs for the cardiac safety statistical analysis; create and maintain procedures for creation of TFLs/statistical outputs; provide statistical support under the supervision of senior team resources and/or department management; may supervise staff in a line management or matrix capacity.

• Develop, test, execute and maintain SAS and R programs for statistical analysis including central tendency analysis, categorical analysis, and concentration-QTc analysis.

• Validate results of statistical analysis by double programming.

• Prepare tables, figures, and listings for statistical analysis as outlined in the statistical analysis plan.

• Perform review of final outputs and reports as it relates to the planned statistical analysis.

• Perform quality checks on CDISC formatted analysis datasets (ADaM).

• Support research programs and provide research results to the senior team resources and/or department management.

• Provide interpretation of results/reports of statistical analysis including descriptions of methodologies and conclusions to the Principal/Sr. Principal Biostatistician, Medical Writing, and/or Scientific Team. Train team members on standard operating procedures and standard methodology.

• Develop process improvements to increase overall operational efficiency.

• Drive ideas for future analyses and data quality efforts.

• Provide guidance and support to junior staff. Develop the Statistical Analysis Plan (SAP) for analysis to be performed in conjunction with senior team resource(s).

• Manage timelines and client commitments and ensure on-time delivery for assigned projects. Input & maintain accurate deliverable status/dates, etc. team tracking tool.

• Assist with the development, coordination, maintenance & enforcement of quality standard compliance, including creating SOPs, SWIs, Playbook/Checklists and Templates for team deliverables.

• Perform supervisory responsibilities as applicable.

• Research and implement analysis techniques for new service lines.

• Participate in Client discussions to communicate statistical methodologies used in the analysis.

• Work with cross-functional team to understand the scope of work for statistical deliverables at the project level.

• Manage process workflow for team.

• Accomplish team results by communicating & managing job expectations; planning, monitoring, coaching & counseling of staff.

• Conduct onboarding and training on Biostats team/practices of staff. Work closely with cross-business unit teams to enhance intra/inter-department communication/practices.

• Participate in hiring process. Implement strategy for team.

• Provide recommendations of strategic concepts.

• Demonstrate proficiency in understanding of team procedures & content/application within team's deliverables and alignment across the organization.

What we're looking for

• A PhD in Statistics, Mathematics or equivalent.

• A Master’s degree in Statistics, Mathematics or equivalent and 4+ years of relevant industry experience.

• Bachelor’s degree in Statistics, Mathematics or equivalent with 10+ years of relevant industry experience.

• Familiarity and experience with ANOVA, t-test, regression, and linear mixed-effects modeling.

• Strong SAS or R programming skills.

• Experience in clinical trials within a CRO or pharmaceutical research organization.

• Familiarity with Clinical protocols and Statistical Analysis Plans, understanding of the pharmaceutical drug development process.

• Excellent verbal and written communication skills.

• Awareness of CDISC SDTM and ADaM standards.

• Strong organization, analytical and communication skills.

• Experience with Windows and Microsoft Office products.

• Experience with TFLs generation.

• Ability to learn quickly, function independently, and handle increasing levels of responsibility.

• Familiarity with Clario products and service lines.

• Previous experience in statistical modeling for clinical trials with focus on QT modeling.

• Ability to work in a group setting and independently, adjusting to rapidly changing priorities.

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.