Innova
A client of Innova Solutions is immediately hiring for a Study Lead Statistician. Position type: Full-time– Contract Duration: 12 Months Location: REMOTE As Study Lead Statistician, you will: Job Description: Experience with R Shiny app development, clinical trial work, 3–5+ years in the pharmaceutical industry, and a postgraduate degree in statistics or a related field. Study Lead Statistician (SLS) – Role Overview: The Study Lead Statistician (SLS) for product-facing work leads statistical activities for clinical studies. This role collaborates closely with cross-functional teams to ensure studies are well-designed, statistically sound, compliant with regulatory standards, and aligned with Client’s internal practices. The SLS ensures operational and statistical integrity throughout the study lifecycle and supports product-level activities such as regulatory submissions and publications. The SLS partners with the Global Statistical Lead to align study-level work with overall product strategy and works alongside the Study Statistician, who manages operational statistical deliverables. Core Responsibilities: Provide statistical input and review for protocols, SAPs, TFL shells, DMC charters, SDF specifications (SDTM and ADaM), randomization specs, and other study documentation. Participate in Clinical Study Team meetings and cross-functional study start-up activities (e.g., CRF development, database specs, IVRS review). Lead and coordinate team meetings for SAP and TFL reviews. Conduct and document statistical analyses for individual studies. Perform QC of ADaM datasets and key endpoints. Apply data-driven modeling during clinical studies. Prepare outputs for Dose Level Review Meetings and participate in DLRMs. Review TFLs for accuracy and consistency. Author analysis reports including Flash Memos and CSR results sections. Collaborate with programming teams on deliverables. Manage timelines for statistical outputs across cross-functional teams. Maintain familiarity with company policies, SOPs, and controlled documents. Support internal and external audits. Minimum Qualifications: Master’s degree in Statistics/Biostatistics or related field with high statistical content and at least 4 years of post-graduate experience in pharma or medical research, or PhD with at least 3 years of experience. Deep understanding of statistical concepts in clinical study design and analysis. Proven ability to lead statistical aspects of complex studies. Experience developing and executing protocols and SAPs, and reviewing CSRs. Proficiency in R programming, including simulations and statistical applications for complex study designs. Experience with R Shiny app development and management. Preferred Qualifications: Master’s degree with 6+ years or PhD with 5+ years of relevant experience. End-to-end leadership of at least three clinical studies or projects. Experience presenting and defending statistical findings in internal and external settings. Life cycle drug development experience across pre-clinical, clinical, and post-marketing phases. Proven ability to work cross-functionally and influence decision-making. Experience with adaptive trial designs and Bayesian statistical methods. Advanced R programming skills, including Shiny app development for clinical trial data. 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. ASK ME HOW. Thank you! Lailun Sheikh Phone: 412-763-1477 Lailun.Sheikh@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range*: $75.00-$100.00 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 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.