Principal Biostatistician
Principal Biostatistician
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1 Vacancy
Job Description
Position Summary:
The Principal Biostatistician acts as the study statistician for a clinical study and/or provides support for a clinical development program. The successful candidate will provide statistical expertise 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 growth strategy of the biostatistics department by participating in process improvement initiatives and keeping abreast of the current statistical methodology development.
Key Responsibilities Include:
- Contribute to study level tasks from statistics perspective including but not limited 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.
- Participates in study/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 crossfunctional teams to meet study/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 studies/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.
Education Registration & Certification:
- PhD in Statistics Biostatistics or Mathematics with 03 years (minimum 5 years for masters degree) of postgraduate experience in the clinical trials setting in the pharmaceutical industry.
Experience:
- Experienced as study statistician and contribute to strategy discussion in crossfunctional settings.
- 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.
- Familiar with ICH guideline FDA/EMA/other regulatory authority guidance.
- Solid understanding of 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.
- Detailedoriented with organization problemsolving 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.
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.
Travel Requirements:
- Up to 20 travel expected.
Benefits and Perks:
Apellis offers a comprehensive benefits package including a 401(k) plan with company match inclusive family building benefits flexible time off summer and winter shutdowns paid family leave disability and life insurance and more! Visithttps://apellis/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop lifechanging 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 preclinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
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.
Required Experience:
Staff IC
Employment Type
Full Time
