Sr. Principal Statistics

Description

Summary of Position:

The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing.

Duties and Responsibilities:

•Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc.

•Review CRF, database design, and edit check specs

•Review study quality surveillance plan and monitor study conduct

•Prepare and/or review SAP, TFL shells and specifications for variable derivation

•Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables

•Provide statistical and validation support for statistical analysis, analysis datasets and TFL

•Review study report, manuscripts and other documents related to statistics

•Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents

•Perform other ad-hoc statistical activities as needed

•Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming

•Participates in monitoring CRO activities and reviewing CRO deliverables

•Other duties as assigned

Work Experience:

•Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience

•Excellent knowledge of SAS computer package

•Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines

•Excellent organizational skills, time management, and ability to meet established deadlines.

•Excellent communication and interpersonal skills to effectively interface with others

•Exceptional interpersonal skills and problem-solving capabilities

•Ability to work independently and collaboratively

•Ability to provide leadership for the CRO statisticians and statistical programmers

Physical and Mental Requirements:

•Ability to multitask

•Adapts to change

•Maintain composure under pressure

•Ability to follow verbal or written instructions and use of effective verbal communications

•Adapts change, adjust change and grasps information quickly

•Examine and observe details

Additional Skills & Qualifications

• Ph.D or MS in Statistics or Biostatistics

• Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience

• Excellent knowledge of SAS computer package

• Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines

• Excellent organizational skills, time management, and ability to meet established deadlines

• Excellent communication and interpersonal skills to effectively interface with others

• Ability to work independently and problem-solve

• Ability to provide leadership for the CRO statisticians and statistical programmers

This is a Contract position based out of Paramus, NJ.

The pay range for this position is $87.00 - $93.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Paramus,NJ.

This position is anticipated to close on Apr 24, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.