BioNTech IMFS
Locations and Job ID
Cambridge, US; Gaithersburg, US; New Jersey, US | Full time | Job ID: 9896
Responsibilities
Partner with Head of Statistical Programming to define and execute a comprehensive programming strategy, including vendor oversight, process automation, and adherence to industry standards.
Lead and oversee a team of internal/FSP programmers and CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs).
Drive the creation, review, and validation of SAS/R programs for SDTM/ADaM datasets, efficacy/safety outputs, and integrated summaries, ensuring reproducibility and compliance with SOPs and regulatory standards.
Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to influence study designs, statistical analysis plans, and submission strategies.
Lead the programming contribution to global regulatory submissions (NDA, BLA, MAA), including submission ready datasets, TLFs, define.xml, and reviews’ guide.
Champion adoption of advanced analytics, automation, and emerging technologies (e.g., R, Python, AI/ML) to optimize workflows and mentor teams on industry innovations.
Establish and maintain robust programming processes, infrastructure, and SOPs to enhance efficiency and standardization across studies and submissions.
Contribute to continuous improvement and global clinical initiatives to strengthen BioNTech’s clinical operation and data analysis capabilities.
Qualifications
Education
Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
Experience
15+ years (10+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting, with a focus on oncology.
Expert knowledge of statistical programming in SAS (Base, Macro, STAT, GRAPH, SQL).
Solid understanding of FDA, EMA, ICH, and global regulations and guidelines.
Deep knowledge of clinical study data standards and reporting requirements, including CDISC (SDTM and ADaM).
Thorough understanding of the drug development process across early- to late-stage development and submission.
Demonstrated expertise in supporting electronic submissions (eCDT, define.xml, reviewer’s guides).
Proven project management skills with the ability to oversee multiple concurrent projects and global vendors.
Expected Pay Range: $220,000/year to $265,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
BioNTech is committed to the wellbeing of its team members and offers a competitive remuneration package and benefits.
How to apply Apply now by sending your application documents (Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter, and contact details) via our online form.
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’ and you will be informed accordingly by your BioNTech recruiter.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment and is an equal‑opportunity employer.
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Responsibilities
Partner with Head of Statistical Programming to define and execute a comprehensive programming strategy, including vendor oversight, process automation, and adherence to industry standards.
Lead and oversee a team of internal/FSP programmers and CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs).
Drive the creation, review, and validation of SAS/R programs for SDTM/ADaM datasets, efficacy/safety outputs, and integrated summaries, ensuring reproducibility and compliance with SOPs and regulatory standards.
Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to influence study designs, statistical analysis plans, and submission strategies.
Lead the programming contribution to global regulatory submissions (NDA, BLA, MAA), including submission ready datasets, TLFs, define.xml, and reviews’ guide.
Champion adoption of advanced analytics, automation, and emerging technologies (e.g., R, Python, AI/ML) to optimize workflows and mentor teams on industry innovations.
Establish and maintain robust programming processes, infrastructure, and SOPs to enhance efficiency and standardization across studies and submissions.
Contribute to continuous improvement and global clinical initiatives to strengthen BioNTech’s clinical operation and data analysis capabilities.
Qualifications
Education
Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
Experience
15+ years (10+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting, with a focus on oncology.
Expert knowledge of statistical programming in SAS (Base, Macro, STAT, GRAPH, SQL).
Solid understanding of FDA, EMA, ICH, and global regulations and guidelines.
Deep knowledge of clinical study data standards and reporting requirements, including CDISC (SDTM and ADaM).
Thorough understanding of the drug development process across early- to late-stage development and submission.
Demonstrated expertise in supporting electronic submissions (eCDT, define.xml, reviewer’s guides).
Proven project management skills with the ability to oversee multiple concurrent projects and global vendors.
Expected Pay Range: $220,000/year to $265,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
BioNTech is committed to the wellbeing of its team members and offers a competitive remuneration package and benefits.
How to apply Apply now by sending your application documents (Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter, and contact details) via our online form.
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’ and you will be informed accordingly by your BioNTech recruiter.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment and is an equal‑opportunity employer.
#J-18808-Ljbffr