Associate Director, Biostatistics

Biometrics and Data Management Waltham, Massachusetts


Description

Position Summary: 

The Associate Director of Biostatistics acts as 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:

  • Contribute in study level tasks from statistics perspective, including but not limiting to: 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.
  • Lead in product level tasks including regulatory interactions and filing and ensure statistical integrity; contribute strategically to the supporting projects from the statistics perspective.
  • Work collaboratively with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
  • Oversee statistical work by CRO and ensure quality deliverables with respect to key performance indicators, metrics, and program level deliverables and timelines.
  • Translate statistical thinking into a strategic input to advance the clinical program.
  • Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
  • 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 3-5 years (minimum 7 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
  • Led in 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
  • Positive and collaborative attitude

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.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

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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.