Associate Director, Biostatistics

Innova Solutions Inc; Austin (TX); Remote; USD 103,000 - 124,000; Full time

Benefits offered by this job

Medical & pharmacy coverage

Dental/vision insurance

401(k)

HSA and FSA

Life Insurance

Pet Insurance

Disability insurance

Sick time

Paid leaves

Employee Assistance Program (EAP)

Job summary

Innova Solutions seeks an Associate Director of Biostatistics (remote) to lead statistical aspects of clinical studies, support regulatory submissions, and provide technical leadership across teams. The role demands a PhD in statistics or biostatistics and substantial post-graduate experience in pharma trials.

Responsibilities include study design, regulatory interactions, and advanced statistical methodology development. Strong SAS/R and CDISC SDTM/ADaM knowledge are required.

Qualifications

• PhD in Statistics or Biostatistics with post-graduate experience in clinical trials.
• Experience contributing to regulatory filings and interactions (NDA/BLA/MAA).
• Expertise in SAS and R with CDISC standards (SDTM/ADaM).

Responsibilities

• Lead indication/study level tasks including regulatory interactions and filing, ensuring statistical integrity.
• Contribute to study design, sample size, SAP and DMC charter; create review of CRFs and documents.
• Provide input on statistical methodology and regulatory data requirements for submissions.
• Develop standards and research in advanced statistical methods; author/regulatory documents.

Skills

Statistical leadership

Regulatory interactions

Study design

SAS

R

Education

PhD in Statistics or Biostatistics

Tools

CDISC SDTM

CDISC ADaM

Job description

Associate Director, Biostatistics

Position type: Full-time- Contract Duration: 3+ Months Location: REMOTE

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

• Lead in indication/study level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
• 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
• 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

We are currently interviewing to fill this and other similar positions.

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.

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.

• 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

Equal Opportunity Employer Statement

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 [phone]. Please indicate the specifics of the assistance needed.

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.

Lailun Sheikh Phone: [phone] [email protected]

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