Biostatistician 5
American Cybersystems, Inc.

A client of Innova Solutions is immediately hiring for a Biostatistician 5

Position type: Full time,Contractto Hire
Job duration: 12 Months
Location: Remote in the U.S. or Canada (East Coast Preferred)

Shift: 8 hours per day Mon to Friday

As a Biostatistician 5, you will:

• Serve as a strategic and operational counterpart to a customer's Biostatistical Lead. This role is fully integrated into the customer's clinical development framework. The individual is responsible for providing statistical leadership and ensuring alignment with the customer's standards, timelines, and strategic objectives across assigned clinical programs.
• Strategic Engagement:

• Liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions.
• Serve as a resource for the customer's biostatistical department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials.
• Participate as lead statistician on major projects, including contributing to clinical development plans, contributing to the customer's internal decision-making, and responding to regulatory queries.
• Provide statistical leadership in submission activities, including the development and production of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) documents.

• Study-Level Statistical Leadership:

• Lead the development and refinement of Statistical Analysis Plans (SAPs) in close coordination with a customer's biostatistics and clinical stakeholders.
• Provide statistical input into protocol design, amendments, and other key study documents.
• Ensure scientific rigor in statistical methodologies.
• Monitor and explore blinded data during study conduct to support strategic decision-making, identification of intercurrent events, and early smoke signal detection related to data collection quality, such as inconsistencies or missingness patterns.
• Mentor and guide the biostatistics and programming team at Client to help ensure alignment with the customer's standards and expectations.
• Programming and Analysis Coordination:
• Partner with the customer's statistical programming team and other biostatisticians to plan and execute dry run activities, ensuring readiness for database lock and final analysis.
• Review and validate key statistical outputs including TLFs (Tables, Listings, Figures), and final study reports.
• Support interpretation of statistical results and contribute to data-driven decision-making.
• Support to Customer's Strategic-level Statistician:
• Act as an extension of the customer's biostatistics function, helping to prepare materials, conduct exploratory analyses, and troubleshoot data or methodological issues.
• Facilitate efficient communication and coordination between client and the customer's teams to maintain alignment and responsiveness.

• Quality and Compliance:

• Ensure deliverables meet the customer's quality standards and comply with regulatory guidelines (e.g., ICH-GCP, FDA, EMA).
• Maintain alignment with the customer's processes, templates, and documentation standards.

The ideal candidate will have:

• MS or PhD degree in Biostatistics or a related field and 8+ years' relevant experience within the life-science industry.
• Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials.
• Expert in strategically collaborating with clinical and drug development experts.
• Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries.
• In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
• Strong working knowledge of SAS or R.
• Excellent knowledge of CDISC Data Standards.
• Rare disease and immunology experience is greatly preferred.

Qualified candidates should APPLY NOW for immediate consideration!
This position is only open to applicants who can be engaged on a W-2 basis.
Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Sapna Singh
678-585-2307
[email protected]

PAY RANGE AND BENEFITS:
Pay Range*: $60 - $71 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• Named One of America's Best Employers for New Grads by Forbes (2024)
• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certifications

Website: https://www.innovasolutions.com/

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https://innovasolutions.workllama.com/atsuser/anonreferafriend and earn $250-$1,000 per referral.

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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