Associate Director, Medical Affairs, Statistical Sciences

This is a fully remote position, open to applicants in California.

📋 Description

• Offer technical and operational assistance for the design, execution, and analysis of post-approval clinical trials, programs, and disease registries

• Work in partnership with Medical Affairs to formulate and implement publication strategies

• Support global market access and health economics teams

• Provide biostatistical services including study design, data analysis, data mining, epidemiology-related evaluations, reimbursement and HTA analysis, real-world evidence, and quality-of-life data interpretation

• Deliver statistical support for Medical Affairs research initiatives, publications, data mining, and evidence-generating activities

• Collaborate with R&D Biostatistics, Clinical Data Management, and Statistical Programming teams

• Ensure the statistical integrity, adequacy, and precision of analyses and interpretation of results

• Develop statistical analysis plans and methodologies for data analysis and interpret results

• Contribute to intricate technical solutions for various projects

• Work with Biometrics teams on statistical analyses and ADaM standards, specifications, and datasets

• Participate in and review clinical study protocols, Case Report Forms, and internal project plans

• Design and implement SAPs for various phases of clinical studies while leading the statistical analysis strategy

• Provide support for ad-hoc analyses and technical consulting on both internal and external projects

⛳️ Requirements

• PhD in Statistics, Biostatistics, or Epidemiology with a focus on statistics and a minimum of 5 years of experience in the pharma/biotech industry, or an MS in Statistics, Biostatistics, or Epidemiology with a focus on statistics and at least 8 years of industry experience

• Understanding of post-marketing study design, data analysis and interpretation, and data-driven decision-making

• Familiarity with therapeutic areas related to rare diseases is advantageous

• Experience in designing and analyzing data from disease and/or product registry studies

• Background in Medical Affairs statistical activities, including RWE data generation, reimbursement filing, data mining, and utilizing external data

• Proficient in statistical programming using R and/or SAS

• Knowledge of regulatory guidelines pertaining to drug development

• Experience with NDA/BLA/MAA submissions is required

• Familiarity with CDISC standards

🏝️ Benefits

• 401(k) plan with company matching

• Medical, dental, and vision insurance plans

• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance

• Short-term and long-term disability benefits provided by the company

• Pet Insurance and Legal Insurance available

• Employee Assistance Program

• Employee Discounts offered

• Opportunities for Professional Development

• Health Savings Account (HSA)

• Flexible Spending Accounts available

• Various incentive compensation plans

• Insurance options for Accident, Critical Illness, and Hospital Indemnity

• Resources for Mental Health support

• Paid leave benefits for new parents

• Eligibility for discretionary annual bonuses or incentive compensation plans

• Access to discretionary stock-based long-term incentives

• Paid time off provided

• Comprehensive benefits package offered