Job Description

A client of Innova Solutions is immediately hiring for a Biostatistician, Analytical Development and Clinical Quality Control Position type: Full-time Contract Duration: 3 months Location: New Haven, Connecticut 06510 As a Biostatistician, Analytical Development and Clinical Quality Control, your responsibilities:We are seeking a highly motivated and detail-oriented statistician to support statistical needs across analytical method development and clinical stability. This contractor position will collaborate closely with analytical scientists and clinical stability teams to ensure data-driven decisions, robust method performance and regulatory compliance. The ideal candidate will provide biostatistics support to other Analytical Development and Clinical Quality Control working groups using statistical analysis to support method comparability assessments, model degradation kinetics and calculate degradation rates using appropriate regression models, develop data visualizations and statistical summaries for internal reports and perform batch analysis and/or standards/results trending. This position may also support the planning, execution, and documentation of clinical stability activities, as needed. You will be responsible for: Cross-functional collaboration: work closely with analytical development and clinical stability teams for to create reporting and analytics solutions that support the quality and timely delivery of data management reports and visualizations required per SOP and study specific data review plans Complies with applicable SOPs and work practices. Draft and revise SOPs related to data management and analyses Interface with key analytical development and clinical quality control stakeholders to generate clear, reproducible statistical reports and result interpretation that align with ICH guidelines and regulatory expectations. Serve as a technical resource to the study teams for data trending for assay performance, data visualization, and reporting tools Serves as a lead for data management, including providing scientific feedback on assay performance via data collection and trending. Reviews ELNs and verifies data in method development, qualification/pre-validation reports Positively contributes to improving the working environment, and engaged in on-going cultural improvement efforts You will need to have:Bachelors or Master’s degree in Statistics, Biostatistics, Applied Mathematics, or related field. A minimum of 2-5+ years relevant experience in a pharmaceutical, biotech, or scientific R&D environment with an emphasis on building reporting and analytics solutions. Strong knowledge of statistical techniques including ANOVA, regression, multivariate analysis, DoE, and time-series/trending analysis. Proficiency with statistical software (e.g., JMP, SAS, R, Minitab, Oracle, PL/SQL relational database design and database programming skills) Excellent interpersonal skills and a strong ability to communicate effectively High level of proficiency in Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) GMP experience in analytical testing and familiarization with testing assays is preferred Understanding of drug development process, batch release testing and data operations required for the reporting in variety of format is preferred (e.g. data review, date trending for assay performance, study reports, regulatory submissions, etc.) The duties of this role are sometimes conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours Qualified candidates should APPLY NOW for immediate consideration! 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. Thank you! Rajesh Chitrada Rajesh.Chitrada@innovasolutions.com (+1) 213 – 797 - 4291

PAY RANGE AND BENEFITS:

Pay Range*: Between $40.00/hr. to $42.75 /hr. *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: Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at 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 hr@innovasolutions.com 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. Thank you! Best regards,.

Job Tags

Full time, Contract work, Temporary work, For contractors, Work experience placement, Work at office, Immediate start, Worldwide, Flexible hours,

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