Associate Director, Biostatistics

A client of Innova Solutions is immediately hiring for an Associate Director, Biostatistics. Position type: Full-time- Contract Duration: 3+ Months Location: REMOTE As Associate Director, Biostatistics, you will: Job Description: The Associate Director of Biostatistics acts as indication/study statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance. Responsibilities: 1. Lead in indication/study level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective 2. 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 3. Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements 4. Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results 5. Contribute to developing standards and research in advanced statistical methodologies 6. Author/review regulatory documents or scientific publications Requirements: 1. 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 2. Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction 3. Experienced as study lead statistician and contributing to strategy discussion in cross functional settings 4. Experienced in study level work including authoring SAP and TFL specification 5. Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance 6. Solid understanding of mathematical and statistical principles 7. 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. Thank you! Lailun Sheikh Phone: 412-763-1477 [email protected] PAY RANGE AND BENEFITS: Pay Range*: $75.00-$90.00 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 echnology an