Purpose of the position
The Senior Manager of Biostatistics is responsible for providing broad statistical support and contributing strategically to project decisions, with a focus on clinical planning, study design, protocol development, sample size / power calculations and simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in-trial data quality review, pre-database lock data quality control, supporting development of table / listing / figure templates, programming and production, oversight of contract or CRO resources, as well as preparation, integration and documentation of clinical regulatory submission package, in accordance with CDISC standards.is expected to act independently as the statistics subject matter expert for all clinical development programs and studies, while ensuring adherence to all regulatory requirements.
Responsabilities
The Sr Manager of Biostatistics is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data and multiplicity handling.
- She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, execution and evaluation of clinical trials.
- In addition, she/he will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics department and also with clinicians, clinical operations, medical writing, regulatory affairs, information technology and other colleagues, service/technology providers, as well as external drug development agencies or organizations.
- She/he will have a good understanding and the capacity to sustain the dialog in consultations or advisory board meetings with biostatistical, clinical and regulatory key opinion leaders about clinical study design, execution and evaluation from the statistical perspective.
- She/he will be able to make appropriate, rational and well-justified decisions in ambiguous situations with incomplete or uncertain information; to prioritize tasks and direct team accordingly
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She/he will be able to collaborate and communicate without boundaries, continuously removes organizational barriers
- She/he will be able take personal accountability for decisions, actions, successes and failures, and fosters the same for others
- She/he will be able to plan and align effectively (steps, resources, timelines etc.)
- She/he will be able to approach priority setting and setting the stage through the lens of execution
- She/he will able to drive submissions
- Experience of rare disease clinical development and regulatory submissions
- Comprehensive knowledge of statistical theory and methods
- Demonstrated ability to apply statistical, programming, and data management knowledge to clinical studies and
- Expertise in SAS and R programming for data management, conversion, review and visualization, statistical analysis, tabulation, listing and graphs of clinical trial data
- Excellent verbal and written communication skills; Leadership and team-ability with effective intercultural competences, diplomacy, negotiation and communication
- Self-management skills with the ability to take initiatives, develop and evaluate alternative scenarios and options, and present them effectively to the colleagues and leadership of the company
- Proficiency in MS Word, Excel, and PowerPoint software programs
- Excellent problem-solving and strategic-thinking skills
- Sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.)
- Excellent written and oral communication and presentation skills
- Ability to identify and address issues proactively in a timely manner
- Master's degree and a minimum of 15 years of relevant industry experience is required
- Education / Certifications (preferred):
- A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 8 years of relevant clinical biostatistics experience in pharma, biotech or medical device industry
Language(s)
- English
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