Director, Biostatistics

Clinical Waltham, Massachusetts


Description

Position Summary:

The Director of Biostatistics acts as the statistical lead for multiple clinical studies and/or a clinical development program. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Participates in regulatory interactions and submissions to the FDA and other regulatory agencies; Contributes to the biometrics effort across the different programs to identify, develop and implement departmental standards, applications, processes, and training.

Key Responsibilities Include:

  • Contributes strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed
  • Provides statistical consultations and strategic inputs in terms of drug development for company's senior management and other staff within the company
  • Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes
  • Develops statistical analysis plans for studies, performs complicated statistical analyses, and oversees the generation of tables, listings and figures for study reports and manuscripts
  • Demonstrates proficiency with SAS statistical procedures, familiarity with specialized statistical software (e.g.,R,  S-PLUS, EaSt)
  • Reviews regulatory documents for accuracy and appropriateness of statistical interpretations
  • Demonstrates ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration
  • Communicates effectively with internal team members, senior management, external experts and regulatory authorities
  • Demonstrates ability to provide coaching and feedback to foster professional development while also supporting business goals
  • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
  • Lead in developing department standards and research in advanced statistical methodologies
  • Author/review regulatory documents or scientific publications.
  • Contribute to project budget/resource planning, re-forecasting, and program milestones

Qualifications:

  • PhD in Statistics, Biostatistics or Mathematics with a minimum of 8 years (minimum 12 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
  • Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics
  • Led NDA/BLA/MAA activities from a statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections
  • Adept at outsourcing and managing biostatistical services provided by CRO’s and contractors
  • Experienced as product lead statistician and contribute to strategy discussion in cross-functional settings; Experienced in managing multiple products and studies and being able to prioritize
  • Experienced in study level work including authoring SAP and TFL specification
  • Develop SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays
  • Lead development of department SOPs
  • Familiar with ICH guideline, FDA/EMA/other regulatory authority guidance
  • Solid understanding of mathematical and statistical principles; Experience in statistical methods (longitudinal data analyses, Bayesian method, adaptive design, Simulations) is preferred
  • Excellent communication and interpersonal skills, with the ability to translate statistical concepts to program strategies
  • Detailed-oriented with organization, problem-solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline
  • Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies
  • The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.