Senior Manager Biostatistics FM
Senior Manager Biostatistics FM
Posted on :
08-03-2025
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1 Vacancy
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Job Description
Job Title: Senior Manager Biostatistics F/M
Job Location: London UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
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 intrial data quality review predatabase 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 indepth understanding of advanced statistical methods including innovative trial designs and endpoints missing data and multiplicity handling.
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 intrial data quality review predatabase 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 indepth 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 stateoftheart innovative statistical methodology for the design execution and evaluation of clinical trials.
- In addition she/he will have the capacity to understand the relevant multidisciplinary 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 welljustified decisions in ambiguous situations with incomplete or uncertain information; to prioritize tasks and direct team accordingly
- 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
- 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 teamability with effective intercultural competences diplomacy negotiation and communication
- Selfmanagement 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 problemsolving and strategicthinking 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 8 years of relevant industry experience is required
- Education / Certifications (preferred):
- A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 6 years of relevant clinical biostatistics experience in pharma biotech or medical device industr
- English
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Employment Type
Full Time
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