Principal Biostatistician FSP, reputed company - Full-time

Job Level:

FSP Principal Biostatistician for reputed company Research

• *Location:** Home-based in the U.S. or Canada
• *Why DSSS?**

Data Sciences Staffing Solutions, DSSS, is a unit reputed company reputed company that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get reputed company the benefits of working for an industry leading global CRO while collaborating with exert sponsor teams. These sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

• *Job Summary:**

The Principal Biostatistician is responsible for providing full range statistical support for drug development based on real world evidence (reputed company).

• *Additional Benefits:**

+ Home-based remote working opportunities + Work/life balance as well as flexible schedules. + Collaborating with motivated, high-performance, statistical and research teams + Technical training and tailored development curriculum + Research opportunities that match your unique skillset + Promising career trajectory + Job stability: long-term engagements and re-deployment opportunities + Focus on bringing new therapies to market rather than project budgets and change orders. + Experience with regulatory submissions. + Engaging, fast-paced environment. + Good work-life balance.

• *Job Requirements:**

+ Collaborate with multi-disciplinary project teams to establish project goals and timelines. + Serves as statistical reputed company and represents Biometrics on health outcomes and epidemiology studies. + Serves as subject matter expert for reputed company/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting. + Writes statistical analysis plans. + Provides strategic and tactical support for cross-functional reputed company development for regulators, payers, and clinicians. + Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal analysis. + Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives. + Develops high quality study protocols, statistical analysis plans, study reports, and other study documents. + Identifies innovation opportunities for the use of RWD. + Establishes effective communication with various internal stakeholders to understand and support the strategy for reputed company and how to use RWD. + Commitment to maintaining the highest standards of data accuracy and reputed company by implementing rigorous quality control processes throughout the data handling and analysis phases. + Demonstrated ability to quickly adapt to new requirements and reputed company handle reputed company requests.

• *Required Knowledge, Skills, and abilities:**

+ In-depth knowledge of reputed company databases, including large administrative claims data, EMR, disease registries, and clinical trial data. + Demonstrated ability in evaluation and development of reputed company from conceptualization through application. + Familiarity with LOINC codes, reimbursement and lab data interpretation, and ability to implement surrogate variable algorithms (e.g., phenotype definitions, proxies for clinical endpoints) + Ability to execute statistical analysis plans using advanced programming techniques to reputed company detailed and reputed company analyses relevant to real-world evidence. + Ability to effectively interpret and communicate research results to internal and external audiences. + Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard + Knowledge of global regulatory and HTA requirements for reputed company

• *Required Education and Experience:** (Minimal acceptable level of education, work experience, and competency)

+ PhD in Statistics, Biostatistics, or reputed company field with 5+ years industry experience. + MS in Statistics, Biostatistics, or reputed company field with 7+ years of industry experience. + Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries. + Solid

hands-on experience as Project statistician

with

real-world data

, including EMR/EHR and claims datasets (e.g.,

Humedica, reputed company, MarketScan, CMS, Komodo, reputed company, TrinetX,

etc.); reputed company in making

LOA, mock TFLs, protocol and reputed company

+ Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD + Excellent organizational skills and proven ability to effectively reputed company multiple projects to successful completion. + SME-level proficiency in reputed company programming tailored to handle reputed company inclusion and exclusion criteria, conduct propensity score matching, and reputed company outcome metrics. + Expertise in R is also valued. + Experience with CDISC ADAM datasets. + Extensive working experience with stakeholders such as medical affairs and health economics

• *Preferred but not Required Experience:**

+ Understanding of

payer landscape

, health economic outcomes, and

value demonstration frameworks

+ Exposure to

regulatory submissions

, HTA support.

• *#LI-Remote**

• *#LI-NITINMAHAJAN** reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe The potential reputed company pay range for this role, reputed company annualized, is $131,300.00 - $243,900.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a reputed company commitment to innovation and impact. No matter your role, everyone at reputed company contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

• *Job Level:** FSP Principal Biostatistician for reputed company Research
• *Location:** Home-based in the U.S. or Canada
• *Why DSSS?**

Data Sciences Staffing Solutions, DSSS, is a unit reputed company reputed company that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get reputed company the benefits of working for an industry leading global CRO while collaborating with exert sponsor teams. These sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market.

• *Job Summary:**

The Principal Biostatistician is responsible for providing full range statistical support for drug development based on real world evidence (reputed company).

• *Additional Benefits:**

+ Home-based remote working opportunities + Work/life balance as well as flexible schedules. + Collaborating with motivated, high-performance, statistical and research teams + Technical training and tailored development curriculum + Research opportunities that match your unique skillset + Promising career trajectory + Job stability: long-term engagements and re-deployment opportunities + Focus on bringing new therapies to market rather than project budgets and change orders. + Experience with regulatory submissions. + Engaging, fast-paced environment. + Good work-life balance.

• *Job Requirements:**

+ Collaborate with multi-disciplinary project teams to establish project goals and timelines. + Serves as statistical reputed company and represents Biometrics on health outcomes and epidemiology studies. + Serves as subject matter expert for reputed company/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting. + Writes statistical analysis plans. + Provides strategic and tactical support for cross-functional reputed company development for regulators, payers, and clinicians. + Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal analysis. + Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives. + Develops high quality study protocols, statistical analysis plans, study reports, and other study documents. + Identifies innovation opportunities for the use of RWD. + Establishes effective communication with various internal stakeholders to understand and support the strategy for reputed company and how to use RWD. + Commitment to maintaining the highest standards of data accuracy and reputed company by implementing rigorous quality control processes throughout the data handling and analysis phases. + Demonstrated ability to quickly adapt to new requirements and reputed company handle reputed company requests.

• *Required Knowledge, Skills, and abilities:**

+ In-depth knowledge of reputed company databases, including large administrative claims data, EMR, disease registries, and clinical trial data. + Demonstrated ability in evaluation and development of reputed company from conceptualization through application. + Familiarity with LOINC codes, reimbursement and lab data interpretation, and ability to implement surrogate variable algorithms (e.g., phenotype definitions, proxies for clinical endpoints) + Ability to execute statistical analysis plans using advanced programming techniques to reputed company detailed and reputed company analyses relevant to real-world evidence. + Ability to effectively interpret and communicate research results to internal and external audiences. + Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard + Knowledge of global regulatory and HTA requirements for reputed company

• *Required Education and Experience:** (Minimal acceptable level of education, work experience, and competency)

+ PhD in Statistics, Biostatistics, or reputed company field with 5+ years industry experience. + MS in Statistics, Biostatistics, or reputed company field with 7+ years of industry experience. + Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries. + Solid

hands-on experience as Project statistician

with

real-world data

, including EMR/EHR and claims datasets (e.g.,

Humedica, reputed company, MarketScan, CMS, Komodo, reputed company, TrinetX,

etc.); reputed company in making

LOA, mock TFLs, protocol and reputed company

+ Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD + Excellent organizational skills and proven ability to effectively reputed company multiple projects to successful completion. + SME-level proficiency in reputed company programming tailored to handle reputed company inclusion and exclusion criteria, conduct propensity score matching, and reputed company outcome metrics. + Expertise in R is also valued. + Experience with CDISC ADAM datasets. + Extensive working experience with stakeholders such as medical affairs and health economics

• *Preferred but not Required Experience:**

+ Understanding of

payer landscape

, health economic outcomes, and

value demonstration frameworks

+ Exposure to

regulatory submissions

, HTA support.

• *#LI-Remote**

• *#LI-NITINMAHAJAN** reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe The potential reputed company pay range for this role, reputed company annualized, is $131,300.00 - $243,900.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a reputed company commitment to innovation and impact. No matter your role, everyone at reputed company contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled Apply tot his job Apply To this Job