- 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.
- PhD in Statistics, Biostatistics or Mathematics with a minimum of 5 years (minimum 8 years for master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry.
- Lead 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.
- This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
- Up to 15% travel expected.
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Associate Director, Biostatistics - Waltham, United States - Apellis
Description
Job Description
Job DescriptionPosition 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:
Education, Registration & Certification:
Experience:
Physical Demands and Work Environment:
Travel Requirements:
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 to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit or follow us on Twitter and LinkedIn
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 pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
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.
