Senior Manager Biostatistics

Innova Solutions has a client that is immediately hiring for Senior Manager Biostatistics Position type: Full Time Contract Duration: 3 months Contract Location: Remote As a Senior Manager Biostatistics, you will: Job Details: Technical Skills: Responsibilities Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results Contribute to developing standards and research in advanced statistical methodologies Author/review regulatory documents or scientific publications Requirements PhD in Statistics or Biostatistics with a minimum of 5 years (min 8 years for Master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction Experienced as study lead statistician and contributing to strategy discussion in cross functional settings Experienced in study level work including authoring SAP and TFL specification Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance Solid understanding of mathematical and statistical principles Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies 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. Suhail Ahmed Email: [email protected] Phone - 678-834-8320 PAY RANGE AND BENEFITS: Pay Range*: $75- - $80 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 Compan es in Atlanta by the