清远招聘

KEY ACCOUNTABILITIES

The Statistician/Senior statistician develops or assists in the development of protocol designs, data analysis and reporting, and regulatory submission in collaboration with internal clinical study team and external stakeholders including business partners, CROs.

The Statistician/Senior Statistician is accountable to:

• Operate in collaboration with study personnel to provide input to study protocol, perform sample size calculation, develop randomization schedule, write/review Reporting Analysis Plan, and write/review Statistical Analysis Report

• Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations

• Respond to statistical queries from other functional areas (e.g. medical, regulatory) and to interact with regulators as required.

• Collaborate with data management in the planning and implementation of data quality assurance plans.

• Provide tailored statistics education to less experienced statisticians or other groups if required

• Participate in peer-review of work products from other statistical colleagues.

• Oversee the process and quality of statistical work contracted out to a CRO or research collaborator

• Perform statistical programming if required

Complexity:

• Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology

• Ability to negotiate and strategically influence other team members

Specialised Knowledge:

• Knowledge of statistical theories and application

• Knowledge of clinical trial design elements and potential issues

• Knowledge of statistical tools such as SAS, nQuery, PASS, East

• Knowledge of Industry SOPs and regulatory requirements relating to statistics and data quality

Minimum Requirements:

• Educated to at least master level in Statistics, Math or equivalent field of study

• At least 3-4 years experience in a multinational pharmaceutical company or Clinical Research Organization (CRO) as a biostatistician

• Proficient in the SAS programming language

• Positive working attitude

Preferred Requirements:

• Experience in early phase drug development, especially in oncology area

• Application of advanced theory and techniques in clinical development

• Self-management skills with a focus on deliverables

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。